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Profile Name | FLT3 exon 14 ins |
Gene Variant Detail | |
Relevant Treatment Approaches | FLT3 Inhibitor |
Molecular Profile | Indication/Tumor Type | Response Type | Relevant Treatment Approaches | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|---|
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Ponatinib | Preclinical - Patient cell culture | Actionable | In a preclinical study, Iclusig (ponatinib) inhibited viability of patient derived acute myeloid leukemia cells harboring FLT3 ITD mutations in culture, and inhibited growth of tumors in cell line xenograft models (PMID: 21482694). | 21482694 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Ponatinib | Phase I | Actionable | In a Phase I trial, Iclusig (ponatinib) resulted in a 25% (3/12) overall response rate, indicated as partial remission or better, in acute myeloid leukemia patients harboring FLT3-ITD (PMID: 23691988). | 23691988 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Entospletinib | Preclinical - Cell culture | Actionable | In a preclinical study, Entospletinib (GS-9973) treatment inhibited proliferation of acute myeloid leukemia cells harboring a FLT3-ITD in culture (PMID: 31992353). | 31992353 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Entospletinib | Preclinical - Patient cell culture | Actionable | In a preclinical study, FLT3-ITD mutations correlated with sensitivity to Entospletinib in patient-derived acute myeloid leukemia samples in an ex vivo assay (PMID: 30333627). | 30333627 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | LAM-003 + Tazemetostat | Preclinical - Cell culture | Actionable | In a preclinical study, LAM-003 and Tazemetostat (EPZ-6438) combination treatment synergistically inhibited viability of acute myeloid leukemia cell lines harboring FLT3 internal tandem duplication (ITD) in culture (PMID: 31751472). | 31751472 | |
FLT3 exon 14 ins | acute myeloid leukemia | no benefit | FLT3 Inhibitor | Rebastinib | Phase I | Actionable | In a Phase I trial, acute myeloid leukemia patients harboring a FLT3 internal tandem duplication did not benefit from treatment with Rebastinib (DCC-2036) (PMID: 27927766). | 27927766 |
FLT3 exon 14 ins | hematologic cancer | sensitive | FLT3 Inhibitor | Gilteritinib | Preclinical - Cell culture | Actionable | In a preclinical study, Xospata (gilteritinib) inhibited growth of transformed hematologic cells expressing FLT3 exon 14 insertions (ITD) in culture (PMID: 31309543). | 31309543 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | ASTX029 | Preclinical - Cell culture | Actionable | In a preclinical study, acute myeloid leukemia cell lines harboring FLT3-ITD mutations were sensitive to treatment with ASTX029 in culture (PMID: 34330842). | 34330842 | |
FLT3 exon 14 ins | hematologic cancer | sensitive | NVP-BSK805 | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing FLT3-ITD were sensitive to treatment with NVP-BSK805 in culture, demonstrating decreased cell viability (PMID: 29296813). | 29296813 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | CCT137690 + Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination therapy of Ibrance (palbociclib) and CCT137690 resulted in a synergistic effect in acute myeloid leukemia cells harboring a FLT3-ITD, demonstrating a greater reduced cell viability compared to either agent alone (PMID: 30544932). | 30544932 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Tandutinib | Preclinical - Cell culture | Actionable | In a preclinical study, Tandutinib (CT53518) treatment inhibited viability of an acute myeloid leukemia cell line harboring FLT3 internal tandem duplication (ITD) in culture (PMID: 31751472). | 31751472 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Momelotinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Momelotinib (CYT387) inhibited proliferation of acute myeloid leukemia cell lines and patient-derived cells harboring FLT3-ITD mutations in culture, and resulted in prolonged survival and reduced leukemic burden in cell line xenograft models (PMID: 34768286). | 34768286 | |
FLT3 exon 14 ins | myeloid leukemia | sensitive | FLT3 Inhibitor | A-419259 | Preclinical - Cell culture | Actionable | In a preclinical study, transformed myeloid leukemia cells expressing FLT3-ITD were sensitive to treatment with A-419259, demonstrating inhibition of cell growth in culture (PMID: 31790499). | 31790499 |
FLT3 exon 14 ins | Advanced Solid Tumor | sensitive | FLT3 Inhibitor | Brigatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Alunbrig (brigatinib) inhibited growth of transformed cells expressing FLT3 ITD in culture (PMID: 27780853). | 27780853 |
FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | IACS-13909 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, IACS-13909 decreased Erk phosphorylation and inhibited proliferation in a acute myeloid leukemia cell line harboring a FLT3-ITD in culture, and inhibited tumor growth and increased overall survival in cell line xenograft models (PMID: 32928921). | 32928921 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | AZD1480 + CUDC-907 | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of CUDC-907 (fimepinostat) and AZD1480 inhibited phosphorylation of Stat5 and induced apoptosis in acute myeloid leukemia cell lines harboring FLT3-ITD mutations in culture, and demonstrated improved activity over either agent alone (PMID: 34099621). | 34099621 | |
FLT3 exon 14 ins | leukemia | predicted - sensitive | GMI-1359 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, GMI-1359 in combination with chemotherapy resulted in significant survival benefit compared to chemotherapy alone (67% vs 30%) in cell line xenograft models of FLT3-ITD leukemia (Blood 2015 126(23):3790). | detail... | |
FLT3 exon 14 ins | hematologic cancer | decreased response | Avapritinib | Preclinical - Cell culture | Actionable | In a preclinical study, Ayvakit (avapritinib) inhibited growth of transformed hematologic cells expressing FLT3 exon 14 insertions (ITD) in culture with reduced potency compared to other kinase inhibitors (PMID: 31309543). | 31309543 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | MRX-2843 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, MRX-2843 inhibited Flt3 activation, resulted in growth inhibition in acute myeloid leukemia cell lines harboring FLT3 internal tandem duplication (ITD) in culture and in cell line xenograft models, and prolonged survival in patient-derived xenograft models (PMID: 27158668). | 27158668 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | HQP1351 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, GZD824 (HQP1351) reduced Flt3 and Stat5 phosphorylation, induced cell cycle arrest and apoptosis, and inhibited growth of acute myeloid leukemia cells harboring FLT3-ITD in culture, and suppressed tumor growth, decreased Flt3 activation, and induced apoptosis in cell line xenograft models (PMID: 32247263). | 32247263 |
FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | FLT3 Inhibitor | Pexidartinib | Phase Ib/II | Actionable | In a Phase I/II trial, treatment with Turalio (pexidartinib) was well-tolerated and resulted in an overall response rate of 21% (19/90) and a composite complete remission (CRc) rate of 11% (10/90) in patients with relapsed/refractory acute myeloid leukemia harboring a FLT3-ITD mutation (PMID: 32330242; NCT01349049). | 32330242 |
FLT3 exon 14 ins | Advanced Solid Tumor | sensitive | FLT3 Inhibitor | Pexidartinib | Preclinical | Actionable | In a preclinical study, PLX3397 inhibited proliferation of transformed cells expressing FLT3-ITD in culture (PMID: 25847190). | 25847190 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | CG-806 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, CG-806 inhibited FLT3 downstream signaling, resulted in growth inhibition of acute myeloid leukemia cells harboring FLT3 exon 14 insertion (ITD) in culture and tumor inhibition in cell line xenograft models (Clin Cancer Res 2017; 23(24_Suppl):Abstract nr 25). | detail... detail... |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Abivertinib | Preclinical - Patient cell culture | Actionable | In a preclinical study, Abivertinib (AC0010) treatment inhibited PI3K signaling and phosphorylation of Btk, Flt3, and Stat5, induced apoptosis and cell cycle arrest, reduced viability, and inhibited colony formation in acute myeloid leukemia cell lines harboring FLT3-ITD mutations, and decreased viability of patient-derived acute myeloid leukemia blasts harboring FLT3-ITD mutations in culture (PMID: 31310800). | 31310800 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | A-419259 | Preclinical - Cell culture | Actionable | In a preclinical study, A-419259 treatment inhibited viability of an acute myeloid leukemia cell line harboring FLT3-ITD in culture (PMID: 31790499). | 31790499 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | ONO-7475 + Venetoclax | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, the combination of ONO-7475 and Venclexta (venetoclax) synergistically inhibited cell viability and induced apoptosis in acute myeloid leukemia cell lines harboring a FLT3-ITD mutation in culture, and reduced leukemia burden and prolonged overall survival in patient-derived xenograft (PDX) and cell line xenograft models with increased efficacy over either agent alone (PMID: 34732043). | 34732043 |
FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | FLT3 Inhibitor | Cytarabine + Quizartinib | Phase Ib/II | Actionable | In a Phase I/II trial, Quizartinib (AC220) in combination with Cytosar-U (cytarabine) resulted in a median overall survival of 6.7 months and a median progression-free survival of 3 months in acute myeloid leukemia patients harboring FLT3 ITD mutations (ASH 59th Annual Meeting and Exposition, Dec 2017, Abstract 723). | detail... |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | CUDC-907 + Gilteritinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, the combination of CUDC-907 (fimepinostat) and Xospata (gilteritinib) synergistically inhibited cell growth, decreased Flt3 signaling, and induced apoptosis in patient-derived acute myeloid leukemia cells harboring FLT3-ITD mutations in culture, and resulted in prolonged survival compared to either agent alone in cell line xenograft models (PMID: 34099621). | 34099621 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | LAM-003 | Preclinical - Patient cell culture | Actionable | In a preclinical study, LAM-003 treatment inhibited colony formation, and reduced viability of acute myeloid cell lines harboring FLT3 internal tandem duplication (ITD) in the presence of stromal factors that confer resistance to Xospata (gilteritinib) and Crenolanib, and induced apoptosis in patient-derived cells in culture, and induced tumor regression, and increased survival in cell line xenograft models (PMID: 31751472). | 31751472 | |
FLT3 exon 14 ins | Advanced Solid Tumor | sensitive | FLT3 Inhibitor | Crenolanib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing FLT3 internal tandem duplication (ITD) demonstrated sensitivity to Crenolanib treatment in culture (PMID: 31751472). | 31751472 |
FLT3 exon 14 ins | hematologic cancer | sensitive | FLT3 Inhibitor | KW-2449 | Preclinical - Cell culture | Actionable | In a preclinical study, transformed hematologic cells expressing FLT3-ITD were sensitive to treatment with KW-2449, demonstrating growth inhibition in culture (PMID: 22858906). | 22858906 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Azacitidine + Sorafenib | Guideline | Actionable | Nexavar (sorafenib) in combination with Vidaza (azacitidine) is included in guidelines for patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (FLT3-ITD) mutation (NCCN.org). | detail... |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Gilteritinib | Guideline | Actionable | Xospata (gilteritinib) is included in the guidelines for patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (FLT3-ITD) mutation (NCCN.org). | detail... |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Gilteritinib | FDA approved - On Companion Diagnostic | Actionable | In a Phase III trial (ADMIRAL) that supported FDA approval, Xospata (gilteritinib) treatment resulted in complete remission (CR) or CR with partial hematologic recovery in 21% (29/138) of patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (ITD; exon 14 insertion), D835, or I836 mutation (FDA.gov; NCT02421939). | detail... detail... |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Gilteritinib | Phase Ib/II | Actionable | In a Phase I/II trial, treatment with Gilteritinib (ASP2215) at a dose of 80mg/day or higher resulted in an overall response rate of 55% (77/141) in patients with relapsed or refractory acute myeloid leukemia harboring FLT3 internal tandem duplication mutations (PMID: 28645776; NCT02014558). | 28645776 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Crenolanib | Preclinical - Cell culture | Actionable | In a preclinical study, Crenolanib inhibited Flt3 phosphorylation and growth of acute myeloid leukemia cell lines harboring FLT3 exon 14 insertions (ITD) in culture (PMID: 31309543). | 31309543 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Crenolanib | Preclinical - Patient cell culture | Actionable | In a preclinical study, FLT3-ITD mutations correlated with sensitivity to Crenolanib in patient-derived acute myeloid leukemia samples in an ex vivo assay (PMID: 30333627). | 30333627 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Crenolanib | Phase I | Actionable | In a Phase I trial, Crenolanib treatment resulted in an overall survival (OS) of 238 days in AML patients harboring FLT3 exon 14 insertions (ITD) that received no prior therapy, and an OS of 158 days in those progressed on TKIs (J Clin Oncol 34, 2016 (suppl; abstr 7008)). | detail... |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | LT-171-861 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, LT-171-861 inhibited cell growth, decreased FLT3 signaling, and induced apoptosis in acute myeloid leukemia cell lines and primary patient-derived peripheral blood mononuclear cells harboring FLT3-ITD mutations in culture, and resulted in tumor regression and prolonged survival in cell line xenograft models (PMID: 33391463). | 33391463 |
FLT3 exon 14 ins | leukemia | sensitive | FLT3 Inhibitor | E6201 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, E6201 induced growth inhibition and apoptosis in leukemia cell lines harboring FLT3 internal tandem duplications (ITD) and reduced tumor burden in xenograft models (PMID: 26822154). | 26822154 |
FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | FLT3 Inhibitor | Cytarabine + Daunorubicin + Quizartinib | Phase I | Actionable | In a Phase I trial (QuANTUM-First), the combination therapy, Quizartinib (AC220) with Cytosar-U (cytarabine) and Cerubidine (daunorubicin), resulted in 67% (6/9) of acute myeloid leukemia patients harboring a FLT3-ITD achieving a composite complete response and two patients achieving morphologic leukemia-free state (PMID: 29139135; NCT01390337). | 29139135 |
FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | FLT3 Inhibitor | Pacritinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Vonjo (pacritinib) induced apoptosis and inhibited proliferation of acute myeloid leukemia cells harboring a FLT3-ITD mutation in culture, and inhibited tumor growth and induced tumor regression in cell line xenograft models (PMID: 22829080). | 22829080 |
FLT3 exon 14 ins | Advanced Solid Tumor | predicted - sensitive | FLT3 Inhibitor | Cabozantinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing a FLT3-ITD mutation were sensitive to Cometriq (cabozantinib) in culture (PMID: 21926191). | 21926191 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | ONO-7475 | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, ONO-7475 treatment inhibited Erk phosphorylation and cell viability in acute myeloid leukemia cell lines harboring a FLT3-ITD mutation in culture, and reduced leukemia burden and prolonged survival in patient-derived xenograft (PDX) and cell line xenograft models (PMID: 34732043). | 34732043 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Cytarabine + Daunorubicin + Midostaurin | FDA approved - On Companion Diagnostic | Actionable | In a Phase III trial that supported FDA approval, treatment with Rydapt (midostaurin), combined with Cytosar-U (cytarabine) and Daunorubicin, improved overall survival (74.7 mo vs 25.6 mo) in patients with FLT3-mutant (D835X and I836X) or FLT3-ITD (exon 14 insertions) acute myeloid leukemia compared to Cytosar-U (cytarabine) and Daunorubicin with placebo (PMID: 28644114). | 28644114 detail... detail... |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | GTP-14564 | Preclinical - Cell culture | Actionable | In a preclinical study, acute myeloid leukemia cells harboring a FLT3 internal tandem duplication were sensitive to GTP-14564 treatment in culture, demonstrating growth inhibition (PMID: 12815052). | 12815052 |
FLT3 exon 14 ins | hematologic cancer | sensitive | FLT3 Inhibitor | Dovitinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells harboring FLT3-ITD were sensitive to treatment with Dovitinib (TKI258) in culture, demonstrating decreased cell viability (PMID: 29296813). | 29296813 |
FLT3 exon 14 ins | acute myeloid leukemia | not applicable | N/A | Guideline | Prognostic | FLT3 internal tandem duplication (FLT3-ITD) mutations are associated with inferior prognosis in acute myeloid leukemia patients with normal karyotype (NCCN.org). | detail... | |
FLT3 exon 14 ins | hematologic cancer | sensitive | FLT3 Inhibitor | KX2-391 | Preclinical - Cell culture | Actionable | In a preclinical study, KX2-391 treatment inhibited cell viability, decreased downstream signaling, and induced apoptosis in cells expressing a FLT3-ITD mutation in culture (PMID: 34217323). | 34217323 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Daunorubicin + LAM-003 | Preclinical - Cell culture | Actionable | In a preclinical study, LAM-003 and Cerubidine (daunorubicin) combination treatment synergistically reduced viability of acute myeloid leukemia cell lines harboring FLT3 internal tandem duplication (ITD) in culture (PMID: 31751472). | 31751472 | |
FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | FLT3 Inhibitor | KW-2449 | Preclinical - Patient cell culture | Actionable | In a preclinical study, FLT3-ITD mutations correlated with sensitivity to KW-2449 in patient-derived acute myeloid leukemia samples in an ex vivo assay (PMID: 30333627). | 30333627 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Semaxanib | Preclinical - Cell culture | Actionable | In a preclinical study, acute myeloid leukemia cells harboring a FLT3 internal tandem duplication were sensitive to Semaxanib (SU5416) in culture, demonstrating inhibition of cell proliferation and inhibition of Flt3, Mapk, and Stat5 phosphorylation (PMID: 12351406). | 12351406 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3/CD3 Fabsc antibody | Preclinical - Cell culture | Actionable | In a preclinical study, treatment of an acute myeloid leukemia (AML) cell lines or patient-derived xenograft (PDX)-derived AML cells harboring a heterozygous FLT3-ITD mutation with a Fabsc FLT3/CD3 bi-specific antibody resulted in near complete eradication of AML cells in culture (PMID: 28895560). | 28895560 | |
FLT3 exon 14 ins | acute myeloid leukemia | not predictive | ARQ 531 | Preclinical - Patient cell culture | Actionable | In a preclinical study, ARQ 531 treatment induced apoptosis in acute myeloid leukemia cells harboring either FLT3 exon 14 insertion (FLT3-ITD) or wild-type FLT3, and inhibited proliferation and reduced colony formation in patient cells derived from acute myeloid leukemia independent of FLT3 status in culture (PMID: 31992353). | 31992353 | |
FLT3 exon 14 ins | leukemia | predicted - sensitive | FLT3 Inhibitor | GMI-1359 + Sorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, combination of GMI-1359 with Nexavar (sorafenib) enhanced apoptosis compared to Nexavar (sorafenib) alone (48.9% vs 36.6%) in leukemia cell lines harboring FLT3 internal tandem duplication (ITD) mutations (Blood 2015 126(23):3790). | detail... |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Sorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, Nexavar (sorafenib) inhibited Flt3 phosphorylation and growth of acute myeloid leukemia cell lines harboring FLT3 exon 14 insertions (ITD) in culture (PMID: 31309543). | 31309543 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Sorafenib | Preclinical - Patient cell culture | Actionable | In a preclinical study, FLT3-ITD mutations correlated with sensitivity to Nexavar (sorafenib) in patient-derived acute myeloid leukemia samples in an ex vivo assay (PMID: 30333627). | 30333627 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Sorafenib | Guideline | Actionable | Nexavar (sorafenib) is included in guidelines as maintenancy therapy for patients with acute myeloid leukemia harboring a FLT3 internal tandem duplication (FLT3-ITD) mutation (NCCN.org). | detail... |
FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | SHP099 | Preclinical - Pdx | Actionable | In a preclinical study, treatment with SHP099 resulted in reduction of CD45-positive leukemic cells and decreased splenomegaly in a human primary tumor-derived xenograft model of acute myeloid leukemia harboring a FLT3-ITD mutation (PMID: 27362227). | 27362227 | |
FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | FLT3 Inhibitor | APG-2575 + HQP1351 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, combination treatment with GZD824 (HQP1351) and APG-2575 synergistically induced apoptosis in acute myeloid leukemia cell lines harboring FLT3-ITD in culture, and led to greater tumor growth inhibition and improved survival than single agent alone in cell line xenograft models (Cancer Res 2021;81(13_Suppl):Abstract nr 1096). | detail... |
FLT3 exon 14 ins | hematologic cancer | sensitive | Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing FLT3 ITD were sensitive to treatment with Ibrance (palbociclib), demonstrating inhibition of cell growth in culture (PMID: 30544932). | 30544932 | |
FLT3 exon 14 ins | leukemia | sensitive | FLT3 Inhibitor | Pexidartinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, PLX3397 inhibited proliferation of human leukemia cells harboring FLT3-ITD in culture and in cell line xenograft models (PMID: 25847190). | 25847190 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | PF-04691502 + Quizartinib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of PF-04691502 and Vanflyta (quizartinib) induced apoptosis and cell-cycle arrest and synergistically inhibited viability of an acute myeloid leukemia cell line harboring a FLT3-ITD mutation in culture (PMID: 34555701). | 34555701 |
FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | OTS167 | Preclinical - Patient cell culture | Actionable | In a preclinical study, OTS167 treatment induced cell death in patient-derived acute myeloid leukemia cells harboring FLT3-ITD in culture (PMID: 33658483). | 33658483 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | MK2206 + Venetoclax | Preclinical - Cell culture | Actionable | In a preclinical study, MK2206 and Venclexta (venetoclax) combination treatment synergistically induced cell death of acute myeloid leukemia cell lines harboring FLT3 internal tandem duplication (ITD) in culture (PMID: 31751472). | 31751472 | |
FLT3 exon 14 ins | hematologic cancer | sensitive | FLT3 Inhibitor | Quizartinib | Preclinical - Cell culture | Actionable | In a preclinical study, Quizartinib (AC220) inhibited growth of transformed hematologic cells expressing FLT3 exon 14 insertions (ITD) in culture (PMID: 31309543). | 31309543 |
FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, Imbruvica (ibrutinib) treatment reduced viability of acute myeloid leukemia cells harboring FLT3-ITD mutations, however, with decreased response compared to cells treated with Abivertinib (AC0010) in culture (PMID: 31310800). | 31310800 | |
FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | Ibrutinib | Preclinical - Patient cell culture | Actionable | In a preclinical study, FLT3-ITD mutations correlated with sensitivity to Imbruvica (ibrutinib) in patient-derived acute myeloid leukemia samples in an ex vivo assay (PMID: 30333627). | 30333627 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | ENMD-2076 | Phase I | Actionable | In a Phase I trial, an acute myeloid leukemia patient with a FLT3-ITD mutation demonstrated anti-leukemia activity when treated with ENMD-2076 (PMID: 27406088). | 27406088 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Gilteritinib + LAM-003 | Preclinical - Cell culture | Actionable | In a preclinical study, LAM-003 and Xospata (gilteritinib) combination treatment reduced viability of acute myeloid leukemia cell lines harboring FLT3 internal tandem duplication (ITD) in culture (PMID: 31751472). | 31751472 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | LAM-003 + Venetoclax | Preclinical - Patient cell culture | Actionable | In a preclinical study, LAM-003 and Venclexta (venetoclax) combination treatment synergistically induced cell death, and inhibited viability of acute myeloid leukemia cell lines and patient-derived cells harboring FLT3 internal tandem duplication (ITD) in culture, and increased survival in a cell line xenograft model (PMID: 31751472). | 31751472 | |
FLT3 exon 14 ins | acute myeloid leukemia | resistant | Avapritinib | Preclinical - Cell culture | Actionable | In a preclinical study, Ayvakit (avapritinib) did not inhibit Flt3 phosphorylation or growth of acute myeloid leukemia cell lines harboring FLT3 exon 14 insertions (ITD) in culture (PMID: 31309543). | 31309543 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Altiratinib | Preclinical - Cell culture | Actionable | In a preclinical study, Altiratinib (DCC-0701) inhibited proliferation of an acute myeloid leukemia cell harboring a FLT3-ITD mutation in culture (PMID: 26285778). | 26285778 | |
FLT3 exon 14 ins | leukemia | sensitive | FLT3 Inhibitor | FN-1501 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, treatment with FN-1501 reduced phoshorylation of FLT3 and downstream STAT5, ERK, and AKT, induced apoptosis and cell-cycle arrest, and decreased proliferation in a human leukemia cell line harboring a FLT3-ITD mutation in culture, and induced tumor regression in xenograft models (PMID: 29357250). | 29357250 |
FLT3 exon 14 ins | hematologic cancer | sensitive | FLT3 Inhibitor | Midostaurin | Preclinical - Cell culture | Actionable | In a preclinical study, Rydapt (midostaurin) inhibited growth of transformed hematologic cells expressing FLT3 exon 14 insertions (ITD) in culture (PMID: 31309543). | 31309543 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Abivertinib + Omacetaxine mepesuccinate | Preclinical - Patient cell culture | Actionable | In a preclinical study, treatment with the combination of Abivertinib (AC0010) and Synribo (omacetaxine mepesuccinate) resulted in increased apoptosis and reduced viability of acute myeloid leukemia (AML) cell lines harboring FLT3-ITD mutations and decreased viability of patient-derived AML cells harboring FLT3-ITD mutations in culture, and reduced tumor burden and increased survival in cell line xenograft models compared to either agent alone (PMID: 31310800). | 31310800 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | E6201 | Preclinical - Cell culture | Actionable | In a preclinical study, E6201 induced apoptosis in blast samples derived from acute myeloid leukemia patients harboring FLT3 internal tandem duplications (ITD) in culture (PMID: 26822154). | 26822154 |
FLT3 exon 14 ins | hematologic cancer | sensitive | FLT3 Inhibitor | HQP1351 | Preclinical - Cell culture | Actionable | In a preclinical study, GZD824 (HQP1351) inhibited growth of transformed cells expressing FLT3-ITD in culture (PMID: 32247263). | 32247263 |
FLT3 exon 14 ins | Advanced Solid Tumor | sensitive | FLT3 Inhibitor | FF-10101 | Preclinical - Cell culture | Actionable | In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD in culture (PMID: 35395091). | 35395091 |
FLT3 exon 14 ins | Advanced Solid Tumor | sensitive | FLT3 Inhibitor | Midostaurin | Preclinical - Cell culture | Actionable | In a preclinical study, Rydapt (midostaurin) demonstrated efficacy in inhibiting proliferation and viability of transformed cells expressing a FLT3-ITD mutation in culture (PMID: 12124173). | 12124173 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | UNC1666 | Preclinical - Cell culture | Actionable | In a preclinical study, UNC1666 inhibited FLT3 phosphorylation and downstream signaling, induced apoptosis of acute myeloid leukemia cells harboring FLT3 exon 14 insertions (ITD) in culture (PMID: 25762638). | 25762638 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | PD-0325901 + Sorafenib | Preclinical - Patient cell culture | Actionable | In a preclinical study, Nexavar (sorafenib) and PD-0325901 synergistically induced apoptosis and inhibited proliferation of acute myeloid leukemia (AML) cell lines harboring FLT3 internal tandem duplication (ITD) mutations in culture, inhibited Erk phosphorylation in FLT3-ITD mutant AML patient cells, and reduced leukemic burden in a FLT3-ITD mutant AML cell line xenograft model (PMID: 28923853). | 28923853 |
FLT3 exon 14 ins | hematologic cancer | sensitive | FLT3 Inhibitor | Sorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, Nexavar (sorafenib) inhibited growth of transformed hematologic cells expressing FLT3 exon 14 insertions (ITD) in culture (PMID: 31309543). | 31309543 |
FLT3 exon 14 ins | Advanced Solid Tumor | sensitive | LAM-003 | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing FLT3 internal tandem duplication (ITD) demonstrated sensitivity to LAM-003 treatment in culture (PMID: 31751472). | 31751472 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Selinexor + Sorafenib | Phase Ib/II | Actionable | In a Phase I/II trial, combination of Selinexor and Nexavar (sorafenib) treatment resulted in complete remission in 29% (4/14) and more than 50% blast reduction in 14% (2/14) of patients with acute myeloid leukemia harboring FLT3 ITD and/or D835 mutations (ASH, 59th Annual Meeting and Exposition, Dec 2017, Abstract 1344; NCT01607892). | detail... |
FLT3 exon 14 ins | hematologic cancer | sensitive | Momelotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Momelotinib (CYT387) decreased phosphorylation of Flt3 and Stat5 and inhibited proliferation of transformed cells expressing a FLT3-ITD mutation in culture (PMID: 34768286). | 34768286 | |
FLT3 exon 14 ins | acute myeloid leukemia | conflicting | FLT3 Inhibitor | Midostaurin | Preclinical - Cell culture | Actionable | In a preclinical study, Rydapt (midostaurin) inhibited Flt3 phosphorylation and growth of acute myeloid leukemia cell lines harboring FLT3 exon 14 insertions (ITD) in culture (PMID: 31309543). | 31309543 |
FLT3 exon 14 ins | acute myeloid leukemia | conflicting | FLT3 Inhibitor | Midostaurin | Preclinical - Cell culture | Actionable | In a preclinical study, co-culturing human stromal cells with an acute myeloid cell line harboring a FLT3 internal tandem duplication (ITD) demonstrated resistance to Rydapt (midostaurin) treatment in culture (PMID: 31751472). | 31751472 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Quizartinib | Phase I | Actionable | In a Phase I trial, acute myeloid leukemia (AML) pediatric patients harboring a FLT3-ITD mutation demonstrated a greater sensitivity to treatment with Quizartinib (AC220) when compared to AML patients with wild-type FLT3, resulting in three complete responses, four with stable disease, and a lower bone marrow blast cell count (PMID: 26920889). | 26920889 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Quizartinib | Phase II | Actionable | In a Phase II trial, Quizartinib (AC220) treatment resulted in a composite complete remission (CCR) in 56% (63/112; 3 complete remission (CR)) of FLT3-ITD-positive patients vs. 36% (16/44; 1 CR) of FLT3-ITD-negative patients with relapsed/refractory acute myeloid leukemia (AML) after first-line therapy, and CCR in 46% (62/136; 5 CR) of FLT3-ITD-positive vs. 30% (12/40; 1 CR) in FLT3-ITD-negative patients with relapsed/refractory AML after salvage chemotherapy or transplant (PMID: 29859851; NCT00989261). | 29859851 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Quizartinib | Preclinical - Cell culture | Actionable | In a preclinical study, Quizartinib (AC220) inhibited proliferation of several acute myeloid leukemia cell lines harboring different FLT3-ITD mutations in culture (PMID: 28895560). | 28895560 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Quizartinib | Preclinical - Cell culture | Actionable | In a preclinical study, Quizartinib (AC220) inhibited Flt3 phosphorylation and growth of acute myeloid leukemia cell lines harboring FLT3 exon 14 insertions (ITD) in culture (PMID: 31309543). | 31309543 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Ipatasertib + Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination therapy of Ibrance (palbociclib) and Alisertib (MLN8237) resulted in a synergistic effect in acute myeloid leukemia cells expressing a FLT3-ITD, demonstrating a greater reduced cell viability compared to either agent alone (PMID: 30544932). | 30544932 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Cytarabine + SKI-G-801 | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of SKI-G-801 and Cytosar-U (cytarabine) resulted in a synergistic effect, demonstrating greater inhibition of proliferation compared to G-749 alone in acute myeloid leukemia cells harboring a FLT3 internal tandem duplication (PMID: 24532805). | 24532805 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Gilteritinib + OTS167 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, combination treatment with OTS167 and Xospata (gilteritinib) synergistically inhibited cell viability and led to inhibition of colony formation in acute myeloid leukuemia (AML) cell lines harboring a FLT3-ITD and patient-derived AML cell lines with a FLT3-ITD in culture, and led to improved overall survival and reduction of leukemia burden in a cell line xenograft model (PMID: 33658483). | 33658483 |
FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | FLT3 Inhibitor | Azacitidine + Quizartinib | Phase Ib/II | Actionable | In a Phase I/II trial, Quizartinib (AC220) in combination with Vidaza (azacitidine) resulted in a median overall survival of 13.4 months and a median progression-free survival of 6.9 months in acute myeloid leukemia patients harboring FLT3 ITD mutations (ASH 59th Annual Meeting and Exposition, Dec 2017, Abstract 723). | detail... |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Decitabine + Sorafenib | Guideline | Actionable | Nexavar (sorafenib) in combination with Dacogen (decitabine) is included in guidelines for patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (FLT3-ITD) mutation (NCCN.org). | detail... |
FLT3 exon 14 ins | hematologic cancer | sensitive | FLT3 Inhibitor | Crenolanib | Preclinical - Cell culture | Actionable | In a preclinical study, Crenolanib inhibited growth of transformed hematologic cells expressing FLT3 exon 14 insertions (ITD) in culture (PMID: 31309543). | 31309543 |
FLT3 exon 14 ins | hematologic cancer | sensitive | NVP-BVB808 | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing FLT3-ITD were sensitive to treatment with NVP-BVB808 in culture, demonstrating decreased cell viability (PMID: 29296813). | 29296813 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | FF-10101 | Phase I | Actionable | In a Phase I trial, FF-10101 treatment was well tolerated, and resulted in a composite complete remission (CRc) in 13% (4/30) and a partial remission (PR) in 13% (4/30) of patients with relapsed or refractory acute myeloid leukemia, 1 of the patients achieved CRc and 2 of the patients achieved PR harbored FLT3 ITD mutations (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7008-7008; NCT03194685). | detail... |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | FF-10101 | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, FF-10101 inhibited Flt3 autophosphorylation and cell growth of leukemic cells in culture and in AML-patient-derived xenograft models with FLT3-ITD mutations (PMID: 29187377). | 29187377 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | MK2206 + Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination therapy of Ibrance (palbociclib) and MK2206 resulted in a synergistic effect in acute myeloid leukemia cells expressing a FLT3-ITD, demonstrating a greater reduced cell viability compared to either agent alone (PMID: 30544932). | 30544932 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Ki23819 | Preclinical - Cell culture | Actionable | In a preclinical study, acute myeloid leukemia cells harboring a FLT3 internal tandem duplication were sensitive to Ki23819 in culture, demonstrating inhibition of autophosphorylation and downstream signaling, and reduced cell proliferation (PMID: 15815726). | 15815726 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | A-1210477 + Venetoclax | Preclinical - Cell culture | Actionable | In a preclinical study, A-1210477 and Venclexta (venetoclax) combination treatment synergistically inhibited viability of acute myeloid leukemia cell lines harboring FLT3 internal tandem duplication (ITD) in culture (PMID: 31751472). | 31751472 | |
FLT3 exon 14 ins | hematologic cancer | sensitive | FLT3 Inhibitor | LT-171-861 | Preclinical - Cell culture | Actionable | In a preclinical study, LT-171-861 inhibited cell viability and decreased FLT3 phosphorylation in transformed cells expressing a FLT3-ITD mutation in culture (PMID: 33391463). | 33391463 |
FLT3 exon 14 ins | hematologic cancer | sensitive | FLT3 Inhibitor | GTP-14564 | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing a FLT3 internal tandem duplication were sensitive to GTP-14564 treatment in culture, demonstrating decreased Stat5 activity and growth inhibition (PMID: 12815052). | 12815052 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | KX2-391 | Preclinical - Patient cell culture | Actionable | In a preclinical study, KX2-391 treatment inhibited cell viability and decreased downstream signaling in acute myeloid leukemia cell lines and patient-derived cells harboring a FLT3-ITD mutation in culture (PMID: 34217323). | 34217323 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Sorafenib + Trametinib | Preclinical - Cell culture | Actionable | In a preclinical study, Nexavar (sorafenib) combined with Mekinist (trametinib) enhanced apoptosis in acute myeloid leukemia cell lines harboring FLT3 internal tandem duplication (ITD) mutations in culture (PMID: 28923853). | 28923853 |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | SKI-G-801 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, SKI-G-801 induced apoptosis in acute myeloid leukemia cells harboring a FLT3 internal tandem duplication in culture, and inhibited tumor growth and induced tumor regression in cell line xenograft models (PMID: 24532805). | 24532805 |
FLT3 exon 14 ins | hematologic cancer | sensitive | Dubermatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Dubermatinib (TP-0903) inhibited growth of transformed cells expressing a FLT3-ITD mutation in culture (PMID: 33268594). | 33268594 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Alisertib + Palbociclib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination therapy of Ibrance (palbociclib) and Alisertib (MLN8237) resulted in a synergistic effect in acute myeloid leukemia cells expressing a FLT3-ITD, demonstrating a greater reduced cell viability compared to either agent alone (PMID: 30544932). | 30544932 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Dubermatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Dubermatinib (TP-0903) treatment resulted in cell cycle arrest and apoptosis, induced differentiation, and inhibited growth of acute myeloid leukemia cell lines harboring a FLT3-ITD mutation in culture, and reduced tumor growth and increased survival in cell line xenograft models (PMID: 33268594). | 33268594 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | GSK690693 + Venetoclax | Preclinical - Cell culture | Actionable | In a preclinical study, GSK690693 and Venclexta (venetoclax) combination treatment synergistically induced cell death of acute myeloid leukemia cell lines harboring FLT3 internal tandem duplication (ITD) in culture (PMID: 31751472). | 31751472 | |
FLT3 exon 14 ins | myelodysplastic syndrome | not applicable | N/A | Guideline | Prognostic | FLT3 internal tandem duplication (FLT3-ITD) mutations are associated with poor prognosis in patients with myelodysplastic syndrome (NCCN.org). | detail... | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Cytarabine + LAM-003 | Preclinical - Cell culture | Actionable | In a preclinical study, LAM-003 and Cytosar-U (cytarabine) combination treatment synergistically reduced viability of an acute myeloid leukemia cell line harboring FLT3 internal tandem duplication (ITD) in culture (PMID: 31751472). | 31751472 | |
FLT3 exon 14 ins | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Cytarabine + LT-171-861 | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of LT-171-861 and Cytosar-U (cytarabine) synergistically inhibited cell viability in acute myeloid leukemia cell lines harboring FLT3-ITD mutations in culture (PMID: 33391463). | 33391463 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04655391 | Phase I | Glasdegib Glasdegib + Ivosidenib Bosutinib + Glasdegib Gilteritinib + Glasdegib Decitabine + Glasdegib + Venetoclax Enasidenib + Glasdegib | Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation | Not yet recruiting | USA | 0 |
NCT04107727 | Phase II | Cytarabine Cytarabine + Idarubicin Cytarabine + Idarubicin + Quizartinib Quizartinib Cytarabine + Quizartinib | Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML) | Active, not recruiting | ESP | 0 |
NCT04872478 | Phase I | MRX-2843 | Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL | Recruiting | USA | 0 |
NCT02283177 | Phase II | Crenolanib + Cytarabine + Daunorubicin | A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations | Completed | USA | 0 |
NCT04168502 | Phase III | Gemtuzumab ozogamicin + Glasdegib Gemtuzumab ozogamicin | Gemtuzumab Chemotherapy MRD Levels; Glasdegib Post-transplant, Adult Untreated, de Novo, Fav Interm Risk AML | Recruiting | ITA | 0 |
NCT04385290 | Phase Ib/II | Cytarabine + Daunorubicin + Gemtuzumab ozogamicin + Midostaurin Cytarabine + Daunorubicin + Gemtuzumab ozogamicin | Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC) | Active, not recruiting | DEU | 0 |
NCT03922100 | Phase Ib/II | NMS-P088 | Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML | Recruiting | ITA | 0 |
NCT02756962 | Phase II | Midostaurin Cytarabine | Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance | Recruiting | USA | 0 |
NCT03552029 | Phase I | Milademetan Tosylate + Quizartinib | Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML) | Terminated | USA | 0 |
NCT02543879 | Phase I | FT-1101 Azacitidine + FT-1101 | Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies | Completed | USA | 0 |
NCT04209725 | Phase II | CPX-351 + Quizartinib | A Study of CPX-351 (Vyxeos) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia | Terminated | USA | 0 |
NCT04518345 | Phase Ib/II | Dubermatinib Azacitidine + Dubermatinib | TP-0903 for the Treatment of FLT3 Mutated Acute Myeloid Leukemia | Recruiting | USA | 0 |
NCT03690115 | Phase II | Ponatinib | Study of Ponatinib (Iclusig) for Prevention of Relapse After Allogeneic Stem Cell Transplantation (Allo-SCT) in FLT3-ITD AML Patients (PONALLO) | Recruiting | FRA | 0 |
NCT04140487 | Phase Ib/II | Azacitidine + Gilteritinib + Venetoclax | Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | Recruiting | USA | 0 |
NCT03674411 | Phase II | Busulfan + Filgrastim + Fludarabine + Melphalan + MGTA-456 + Mycophenolate mofetil + Tacrolimus Cyclophosphamide + Filgrastim + Fludarabine + MGTA-456 + Mycophenolate mofetil + Tacrolimus | Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy | Active, not recruiting | USA | 0 |
NCT04493138 | Phase Ib/II | Azacitidine + Quizartinib | Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations | Recruiting | USA | 0 |
NCT03836209 | Phase II | Cytarabine + Daunorubicin + Gilteritinib Cytarabine + Daunorubicin + Midostaurin Cytarabine Midostaurin | Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia | Recruiting | USA | 0 |
NCT03735875 | Phase Ib/II | Quizartinib + Venetoclax | Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia | Unknown status | USA | 0 |
NCT02752035 | Phase II | Gilteritinib Azacitidine + Gilteritinib Azacitidine | A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 6 |
NCT04669067 | Phase Ib/II | KRT-232 + TL-895 | TL-895 and KRT-232 Study in Acute Myeloid Leukemia | Recruiting | USA | ITA | FRA | ESP | DEU | AUT | 2 |
NCT05010122 | Phase Ib/II | Decitabine and Cedazuridine + Gilteritinib + Venetoclax | ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | Recruiting | USA | 0 |
NCT02927262 | Phase III | Gilteritinib | A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | 15 |
NCT02400255 | Phase II | Crenolanib | Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients | Active, not recruiting | USA | 0 |
NCT03709758 | Phase I | Cytarabine + Daunorubicin + Venetoclax | Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Naive AML | Suspended | USA | 0 |
NCT02668653 | Phase III | Cytarabine + Daunorubicin + Idarubicin Cytarabine + Daunorubicin + Idarubicin + Quizartinib | Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) (QuANTUM-First) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 21 |
NCT03513484 | Phase I | Azacitidine + Nintedanib | Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia | Recruiting | USA | 0 |
NCT03661307 | Phase Ib/II | Decitabine + Quizartinib + Venetoclax | Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome | Recruiting | USA | 0 |
NCT03365661 | Phase II | ALT-803 | QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML | Withdrawn | USA | 0 |
NCT03793478 | Phase Ib/II | Etoposide Cytarabine + Fludarabine + Methotrexate + Prednisolone + Quizartinib Cytarabine + Daunorubicin + Fludarabine + Methotrexate + Prednisolone + Quizartinib Cytarabine + Daunorubicin + Fludarabine + Hydrocortisone + Methotrexate + Quizartinib Cytarabine + Fludarabine + Methotrexate + Prednisolone Quizartinib | Safety and Effectiveness of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood | Recruiting | USA | ITA | FRA | ESP | CAN | BEL | 5 |
NCT05024552 | Phase I | CPX-351 + Gilteritinib | Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML | Recruiting | USA | 0 |
NCT01892371 | Phase Ib/II | Azacitidine + Quizartinib Cytarabine + Quizartinib | Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome | Active, not recruiting | USA | 0 |
NCT02039726 | Phase III | Cytarabine + Fludarabine Cytarabine + Etoposide + Mitoxantrone Quizartinib Filgrastim + Idarubicin | (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive | Completed | USA | ITA | FRA | ESP | DEU | CAN | BEL | 12 |
NCT04240002 | Phase Ib/II | Cytarabine + Filgrastim + Fludarabine + Gilteritinib | A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML) | Recruiting | USA | ITA | ESP | DEU | CAN | 1 |
NCT02270463 | Phase Ib/II | Tagraxofusp-erzs | SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission | Terminated | USA | 0 |
NCT04336982 | Phase Ib/II | Azacitidine + CC-90009 + Venetoclax CC-90009 + Gilteritinib | A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia | Recruiting | USA | FRA | CAN | 1 |
NCT04027309 | Phase III | Midostaurin Gilteritinib | A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy (HOVON 156 AML) | Recruiting | FRA | ESP | DEU | BEL | AUT | 9 |
NCT03250338 | Phase III | Cytarabine + Filgrastim + Fludarabine + Idarubicin + Mitoxantrone Crenolanib + Cytarabine + Filgrastim + Fludarabine + Idarubicin + Mitoxantrone | Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | 0 |
NCT02997202 | Phase III | Gilteritinib | A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 9 |
NCT04817241 | Phase Ib/II | Cytarabine + Daunorubicin Decitabine and Cedazuridine + Venetoclax | Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients | Recruiting | USA | 0 |