Therapy Detail
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| Therapy Name | Ibrutinib |
| Synonyms | |
| Therapy Description |
Imbruvica (ibrutinib) is a selective, irreversible inhibitor of Bruton's tyrosine kinase (BTK), which promotes apoptosis and inhibits B-cell mediated signaling pathways, and has additional activity against ERBB2 (HER2) and EGFR (PMID: 20615965, PMID: 21422473, PMID: 27678331). Imbruvica (Ibrutinib) is FDA approved for use in patients with mantle cell lymphoma, CLL/SLL and CLL/SLL with del 17p, Waldenstroem’s macroglobulinemia, marginal zone lymphoma, and in combination with Rituxan (rituximab) for untreated CLL/SLL (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Ibrutinib | Imbruvica | PCI-32765 | BTK inhibitor 36 EGFR Inhibitor (Pan) 61 HER2 Inhibitor 41 | Imbruvica (ibrutinib) is a selective, irreversible inhibitor of Bruton's tyrosine kinase (BTK), which promotes apoptosis and inhibits B-cell mediated signaling pathways, and has additional activity against ERBB2 (HER2) and EGFR (PMID: 20615965, PMID: 21422473, PMID: 27678331). Imbruvica (Ibrutinib) is FDA approved for use in patients with mantle cell lymphoma, CLL/SLL and CLL/SLL with del 17p, Waldenstroem’s macroglobulinemia, marginal zone lymphoma, and in combination with Rituxan (rituximab) for untreated CLL/SLL (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| BTK C481R | diffuse large B-cell lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, diffuse large B-cell lymphoma cell lines expressing BTK C481R demonstrated resistance to Imbruvica (ibrutinib) in culture (PMID: 36183831). | 36183831 |
| BTK T316A | lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, lymphoma cells expressing BTK T316A were resistant to Imbruvica (ibrutinib) in culture (PMID: 27626698) | 27626698 |
| BTK Y315N | lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, lymphoma cell lines expressing BTK Y315N were resistant to treatment with Imbruvica (ibrutinib) in culture (PMID: 33419778). | 33419778 |
| TP53 loss | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Ibrutinib | Guideline | Actionable | Imbruvica (ibrutinib) is indicated in the guidelines as first line therapy and second line and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 loss (NCCN.org). | detail... |
| BTK P597S | lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, lymphoma cell lines expressing BTK P597S were resistant to treatment with Imbruvica (ibrutinib) in culture (PMID: 33419778). | 33419778 |
| BTK T474M BTK C481T | Advanced Solid Tumor | predicted - resistant | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) failed to inhibit Btk activity in a cell line expressing BTK variants T474M and C481T in culture (PMID: 33526860). | 33526860 |
| BTK C481F | chronic lymphocytic leukemia | predicted - resistant | Ibrutinib | Preclinical | Actionable | In a preclinical study, patients with BTK C481 were predicted to have resistance to Imbruvica (ibrutinib) since C481 is in the covalent binding site of the BTK inhibitor and C481F interferes with drug binding (PMID: 24869597). | 24869597 |
| BTK T474S BTK C481S | Advanced Solid Tumor | predicted - sensitive | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) resulted in reduced Btk activity in a cell line expressing BTK variants T474S and C481S in culture (PMID: 33526860). | 33526860 |
| TP53 mutant | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Ibrutinib | Guideline | Actionable | Imbruvica (ibrutinib) is indicated in the guidelines as first line therapy and second line and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org). | detail... |
| BTK C481T | lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, lymphoma cells over expressing BTK C481T were resistant to Imbruvica (ibrutinib) in culture (PMID: 27282255). | 27282255 |
| BTK T474A | Advanced Solid Tumor | predicted - sensitive | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) resulted in reduced Btk activity in cell lines expressing BTK T474A in culture (PMID: 33526860). | 33526860 |
| BTK C481S | lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, lymphoma cells expressing BTK C481S were resistant to Imbruvica (ibrutinib) in culture (PMID: 27626698) | 27626698 |
| BTK P566L | lymphoma | sensitive | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, lymphoma cell lines expressing BTK P566L were sensitive to Imbruvica (ibrutinib) treatment in culture, demonstrating decreased cell viability (PMID: 33419778). | 33419778 |
| BTK C481S | chronic lymphocytic leukemia | resistant | Ibrutinib | Preclinical - Patient cell culture | Actionable | In a preclinical study, primary chronic lymphocytic leukemia cells derived from patients who acquired BTK C481S following Imbruvica (ibrutinib) treatment demonstrated resistance to Imbruvica (ibrutinib) in culture (PMID: 30093506). | 30093506 |
| BTK C481S | chronic lymphocytic leukemia | resistant | Ibrutinib | Clinical Study - Cohort | Actionable | In a clinical study, BTK C481S was identified as an acquired mutation in patients with chronic lymphocytic leukemia who relapsed while on Imbruvica (ibrutinib), and was demonstrated to confer resistance to Imbruvica (ibrutinib) in preclinical studies (PMID: 24869598). | 24869598 |
| BTK K433T | lymphoma | sensitive | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a lymphoma cell line expressing BTK K433T was sensitive to Imbruvica (ibrutinib) treatment in culture, demonstrating decreased cell viability (PMID: 33419778). | 33419778 |
| BTK R77S | lymphoma | sensitive | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, lymphoma cell lines expressing BTK R77S were sensitive to Imbruvica (ibrutinib) treatment in culture, demonstrating decreased cell viability (PMID: 33419778). | 33419778 |
| 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 |
| BTK T474V | Advanced Solid Tumor | predicted - sensitive | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) resulted in reduced Btk activity in cell lines expressing BTK T474V in culture (PMID: 33526860). | 33526860 |
| BTK T474I BTK C481S | Advanced Solid Tumor | predicted - resistant | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) failed to inhibit Btk activity in a cell line expressing BTK variants T474I and C481S in culture (PMID: 33526860). | 33526860 |
| BTK C481S | mantle cell lymphoma | resistant | Ibrutinib | Case Reports/Case Series | Actionable | In a clinical study, BTK C481S was identified as an acquired mutation that confers resistance to Imbruvica (ibrutinib) in two patients with mantle cell lymphoma who relapsed after a durable response (PMID: 25082755). | 25082755 |
| CSF3R Q741* | Advanced Solid Tumor | sensitive | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing CSF3R Q741* were sensitive to treatment with Imbruvica (ibrutinib) in culture, demonstrating a reduced cell proliferation (PMID: 29977015). | 29977015 |
| TP53 mutant | chronic lymphocytic leukemia | sensitive | Ibrutinib | Guideline | Actionable | Imbruvica (ibrutinib) is included in the guidelines as first-line therapy for patients with advanced chronic lymphocytic leukemia harboring TP53 mutations and for patients with relapsed or refractory disease (PMID: 33091559; ESMO.org). | 33091559 detail... |
| BTK C481F | mantle cell lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a mantle cell lymphoma cell line developed resistance to Imbruvica (ibrutinib) after prolonged exposure in culture, and was subsequently found to have acquired BTK C481F (PMID: 36661329). | 36661329 |
| BTK T474M BTK C481S | Advanced Solid Tumor | predicted - resistant | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) failied to inhibit Btk activity in a cell line expressing BTK variants T474M and C481S in culture (PMID: 33526860). | 33526860 |
| BTK T474E | Advanced Solid Tumor | predicted - sensitive | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) resulted in reduced Btk activity in cell lines expressing BTK T474E in culture (PMID: 33526860). | 33526860 |
| BTK C481T | Advanced Solid Tumor | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells over expressing BTK C481T were resistant to Imbruvica (ibrutinib) in culture (PMID: 27282255). | 27282255 |
| CSF3R T618I | Advanced Solid Tumor | sensitive | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, cells expressing CSF3R T618I were sensitive to treatment with Imbruvica (ibrutinib) in culture, demonstrating a reduced cell proliferation (PMID: 29977015). | 29977015 |
| BTK Y361H | lymphoma | sensitive | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a lymphoma cell line expressing BTK Y361H was sensitive to Imbruvica (ibrutinib) treatment in culture, demonstrating decreased cell viability (PMID: 33419778). | 33419778 |
| BTK A428D | diffuse large B-cell lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK A428D demonstrated resistance to Imbruvica (ibrutinib) in culture (PMID: 35196427). | 35196427 |
| BTK T474A BTK C481S | Advanced Solid Tumor | predicted - sensitive | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) resulted in reduced Btk activity in cell lines expressing BTK variants T474A and C481S in culture (PMID: 33526860). | 33526860 |
| BTK T474M | Advanced Solid Tumor | predicted - resistant | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) failed to inhibit Btk activity in cell lines expressing BTK T474M in culture (PMID: 33526860). | 33526860 |
| BTK V416L | diffuse large B-cell lymphoma | sensitive | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, Imbruvica (ibrutinib) treatment inhibited phosphorylation of Btk and decreased viability of a diffuse large B-cell lymphoma cell line expressing BTK V416L in culture (PMID: 35196427). | 35196427 |
| BTK C481Y | diffuse large B-cell lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, diffuse large B-cell lymphoma cell lines expressing BTK C481Y demonstrated resistance to Imbruvica (ibrutinib) in culture (PMID: 36183831). | 36183831 |
| BTK T474I | diffuse large B-cell lymphoma | sensitive | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, Imbruvica (ibrutinib) treatment inhibited phosphorylation of Btk and decreased viability of a diffuse large B-cell lymphoma cell line expressing BTK T474I in culture (PMID: 35196427). | 35196427 |
| ERBB4 over exp | marginal zone lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a marginal zone lymphoma cell line with ERBB4 overexpression demonstrated resistance to Imbruvica (ibrutinib) in culture (PMID: 38052765). | 38052765 |
| BTK T474S | Advanced Solid Tumor | predicted - sensitive | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) resulted in reduced Btk activity in cell lines expressing BTK T474S in culture (PMID: 33526860). | 33526860 |
| BTK C481S | diffuse large B-cell lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK C481S demonstrated resistance to Imbruvica (ibrutinib) in culture (PMID: 38301010). | 38301010 |
| BTK C481S | diffuse large B-cell lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK C481S demonstrated resistance to Imbruvica (ibrutinib) in culture (PMID: 35196427). | 35196427 |
| BTK C481S | diffuse large B-cell lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, diffuse large B-cell lymphoma cell lines expressing BTK C481S demonstrated resistance to Imbruvica (ibrutinib) in culture (PMID: 36183831). | 36183831 |
| BTK V568I | lymphoma | sensitive | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, lymphoma cell lines expressing BTK V568I were sensitive to Imbruvica (ibrutinib) treatment in culture, demonstrating decreased cell viability (PMID: 33419778). | 33419778 |
| BTK M437R | diffuse large B-cell lymphoma | sensitive | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, Imbruvica (ibrutinib) treatment inhibited phosphorylation of Btk and decreased viability of a diffuse large B-cell lymphoma cell line expressing BTK M437R in culture (PMID: 35196427). | 35196427 |
| BTK C481F | diffuse large B-cell lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, diffuse large B-cell lymphoma cell lines expressing BTK C481F demonstrated resistance to Imbruvica (ibrutinib) in culture (PMID: 36183831). | 36183831 |
| BTK C481F | diffuse large B-cell lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, the BTK C481F mutation was identified in diffuse large B-cell lymphoma cells that acquired resistance to Imbruvica (ibrutinib) in culture (PMID: 28178345). | 28178345 |
| BTK T474I | Advanced Solid Tumor | predicted - sensitive | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) resulted in reduced Btk activity in cell lines expressing BTK T474I in culture (PMID: 33526860). | 33526860 |
| BTK C481X | chronic lymphocytic leukemia | predicted - resistant | Ibrutinib | Phase II | Actionable | In a Phase II trial, BTK C481X and/or PLCG2 mutations were identified in 80% (8/10) of patients with progressive disease and in 20% (1/5) of patients with prolymphocytic transformation of chronic lymphocytic leukemia while on Imbruvica (ibrutinib) treatment (PMID: 28049639, NCT01500733). | 28049639 |
| BTK E90K | lymphoma | sensitive | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, lymphoma cell lines expressing BTK E90K were sensitive to Imbruvica (ibrutinib) treatment in culture, demonstrating decreased cell viability (PMID: 33419778). | 33419778 |
| BTK T474Q | Advanced Solid Tumor | predicted - sensitive | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) resulted in reduced Btk activity in a cell line expressing BTK T474Q in culture (PMID: 33526860). | 33526860 |
| BTK T474N | Advanced Solid Tumor | predicted - sensitive | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) resulted in reduced Btk activity in cell lines expressing BTK T474N in culture (PMID: 33526860). | 33526860 |
| BTK C481A | chronic lymphocytic leukemia | predicted - resistant | Ibrutinib | Preclinical | Actionable | In a preclinical study, patients with BTK C481 were predicted to have resistance to Imbruvica (ibrutinib) since C481 is in the covalent binding site of the BTK inhibitor and C481A interferes with drug binding (PMID: 24869597). | 24869597 |
| BTK T474L | Advanced Solid Tumor | predicted - sensitive | Ibrutinib | Preclinical - Biochemical | Actionable | In a preclinical study, treatment with Imbruvica (ibrutinib) resulted in reduced Btk activity in cell lines expressing BTK T474L in culture (PMID: 33526860). | 33526860 |
| BTK L528W | diffuse large B-cell lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK L528W demonstrated resistance to Imbruvica (ibrutinib) in culture (PMID: 35196427). | 35196427 |
| BTK L528W | diffuse large B-cell lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK L528W demonstrated resistance to Imbruvica (ibrutinib) in culture (PMID: 38301010). | 38301010 |
| BTK L528W | diffuse large B-cell lymphoma | resistant | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, diffuse large B-cell lymphoma cell lines expressing BTK L528W demonstrated resistance to Imbruvica (ibrutinib) in culture (PMID: 36183831). | 36183831 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03620903 | Phase II | Rituximab Bortezomib Ibrutinib | Efficacy of First Line B-RI for Treatment Naive Waldenstrom's Macroglobulinemia | Active, not recruiting | DEU | 1 |
| NCT01974440 | Phase III | Ibrutinib Bendamustine + Rituximab Cyclophosphamide + Doxorubicin + Prednisone + Vincristine Sulfate | A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma | Completed | USA | GBR | FRA | ESP | DEU | BEL | AUS | 12 |
| NCT02662296 | Phase II | Idelalisib Ibrutinib | Ibrutinib or Idelalisib in Treating Patients With Persistent or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma After Donor Stem Cell Transplant | Withdrawn | USA | 0 |
| NCT03734016 | Phase III | Ibrutinib Zanubrutinib | A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia | Completed | 1 | |
| NCT03943342 | Phase II | Ibrutinib Ibrutinib + Venetoclax | Ibrutinib and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia After Ibrutinib Resistance | Withdrawn | 0 | |
| NCT04446962 | Phase Ib/II | Ibrutinib Lenalidomide | LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV) (LOC-R01) | Recruiting | FRA | 0 |
| NCT06482684 | Phase II | Ibrutinib Ibrutinib + Rituximab Bendamustine + Ibrutinib + Rituximab Cyclophosphamide + Doxorubicin + Ibrutinib + Prednisone + Rituximab + Vincristine Sulfate Brexucabtagene autoleucel Cisplatin + Cytarabine + Dexamethasone + Rituximab | CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma (CARMAN) | Recruiting | DEU | 0 |
| NCT02801578 | Phase I | Ibrutinib | A Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL) | Completed | USA | 0 |
| NCT03877055 | Phase Ib/II | Copanlisib + Ibrutinib Ibrutinib | A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma | Completed | USA | 0 |
| NCT03267186 | Phase II | Ibrutinib | Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant | Completed | USA | 0 |
| NCT02436707 | Phase II | Ibrutinib Cisplatin + Dexamethasone + Gemcitabine + Rituximab | Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma | Recruiting | CAN | 0 |
| NCT02943473 | Phase II | Ibrutinib | Study on the Effect of Ibrutinib on High Risk Smoldering Multiple Myeloma Patients | Terminated | USA | 0 |
| NCT05963074 | Phase II | Ibrutinib Ibrutinib + Venetoclax | A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia (TAILOR) | Recruiting | USA | ITA | FRA | ESP | CAN | 3 |
| NCT02272686 | Phase II | Ibrutinib | Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma | Terminated | USA | 0 |
| NCT04802590 | Phase II | Ibrutinib Ibrutinib + Venetoclax | Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma | Recruiting | GBR | FRA | BEL | 0 |
| NCT05254743 | Phase III | Ibrutinib Pirtobrutinib | A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN-CLL-314) | Recruiting | USA | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 12 |
| NCT02869633 | Phase II | Ibrutinib | Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant | Completed | USA | 0 |
| NCT02581930 | Phase II | Ibrutinib | Ibrutinib in Treating Patients With Refractory Stage IV Cutaneous Melanoma | Active, not recruiting | USA | 0 |
| NCT03219047 | Phase I | Ibrutinib | The EXPLORE Trial: Study Evaluating Xenografts to Personalize Therapies (PDX) in Relapsed Mantle Cell Lymphoma to Optimize Response | Completed | USA | 0 |
| NCT01804686 | Phase III | Ibrutinib | A Long-term Extension Study of PCI-32765 (Ibrutinib) | Enrolling by invitation | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 20 |
| NCT02006485 | Phase I | Ublituximab + Umbralisib Ibrutinib | Ublituximab in Combination With TGR-1202 in Patients With B-cell Malignancies | Completed | USA | 0 |
| NCT02443077 | Phase III | Cyclophosphamide Carmustine + Cytarabine + Etoposide + Melphalan Ibrutinib | Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma | Active, not recruiting | USA | 1 |
| NCT04662255 | Phase III | Ibrutinib Zanubrutinib Pirtobrutinib Acalabrutinib | Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321) | Active, not recruiting | USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 14 |
| NCT02477696 | Phase III | Acalabrutinib Ibrutinib | Elevate CLL R/R: Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia | Active, not recruiting | USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUS | 5 |
| NCT02575300 | Phase II | Ibrutinib | Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors | Completed | USA | 0 |
| NCT03053440 | Phase III | Ibrutinib Zanubrutinib | A Study Comparing BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM) | Completed | USA | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUS | 4 |
| NCT02518555 | Phase II | Ibrutinib | Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | Active, not recruiting | USA | 0 |
| NCT03207555 | Phase II | Ibrutinib | Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL) | Active, not recruiting | USA | 0 |
| NCT02309580 | Phase I | Ibrutinib | Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma | Completed | USA | 0 |
| NCT01109069 | Phase II | Ibrutinib | Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia | Completed | USA | 0 |
| NCT02129062 | Phase II | Ibrutinib | Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia | Terminated | USA | 0 |
| NCT03112174 | Phase III | Ibrutinib Ibrutinib + Venetoclax | Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO) | Completed | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 7 |
| NCT04212013 | Phase III | Ibrutinib Ibrutinib + Rituximab | A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma | Active, not recruiting | USA | 0 |
| NCT06136559 | Phase III | Ibrutinib ARQ 531 Acalabrutinib | A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011) | Recruiting | USA | NZL | GBR | ESP | DEU | CAN | 11 |
| NCT02007044 | Phase II | Ibrutinib Ibrutinib + Rituximab | Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia | Active, not recruiting | USA | 0 |
| NCT02321540 | Phase Ib/II | Ibrutinib | A Phase I/II Study of Ibrutinib in Previously Treated Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer | Completed | USA | 0 |
| NCT04263480 | Phase III | Carfilzomib + Ibrutinib Ibrutinib | Efficacy and Safety of Carfilzomib in Combination With Ibrutinib vs Ibrutinib in Waldenström's Macroglobulinemia (CZAR-1) | Recruiting | DEU | AUT | 1 |
| NCT02242097 | Phase II | Ibrutinib | Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma | Active, not recruiting | USA | 0 |
| NCT02966730 | Phase I | Ibrutinib | Ibrutinib for Patients With Follicular Lymphoma Without Complete Response to Initial Chemoimmunotherapy | Terminated | USA | 0 |
| NCT03282396 | Phase II | Ibrutinib | Ibrutinib in Treating Participants With Untreated High Risk Smoldering Mantle Cell Lymphoma | Active, not recruiting | USA | 0 |
| NCT02301156 | Phase III | Ibrutinib + Ublituximab Ibrutinib | Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL) | Completed | USA | 1 |
| NCT02649387 | Phase II | Ibrutinib | Ibrutinib in Treating Minimal Residual Disease in Patients With Chronic Lymphocytic Leukemia After Front-Line Therapy (MERIT) | Active, not recruiting | USA | 0 |
| NCT05694312 | Phase II | Ibrutinib | Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL | Recruiting | ITA | 0 |
| NCT01841723 | Phase II | Ibrutinib | Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia | Active, not recruiting | USA | 0 |
| NCT02207062 | Phase I | Ibrutinib | Ibrutinib in Treating Patients With Relapsed or Refractory Transformed Indolent B-cell Non-Hodgkin Lymphoma | Completed | USA | 0 |
| NCT03535350 | Phase I | Ibrutinib Ibrutinib + Temozolomide | Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma | Active, not recruiting | USA | 0 |
| NCT02352558 | Phase I | Imatinib Napabucasin Bortezomib Ibrutinib Dexamethasone | A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies | Completed | USA | 0 |
| NCT04665115 | Phase II | Ibrutinib | Ibrutinib for the Treatment of Patients With B-Cell Malignancies Who Are Infected With Coronavirus Disease 2019 (COVID-19) | Withdrawn | USA | 0 |
| NCT02643667 | Phase Ib/II | Ibrutinib | A Study of Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer | Completed | USA | 0 |
| NCT03088878 | Phase Ib/II | Cirmtuzumab Cirmtuzumab + Ibrutinib Ibrutinib | A Study of the Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid Malignancies | Active, not recruiting | USA | 0 |
| NCT02629809 | Phase II | Cyclophosphamide + Fludarabine + Ibrutinib + Obinutuzumab Ibrutinib + Obinutuzumab Ibrutinib | Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients With Chronic Lymphocytic Leukemia | Active, not recruiting | USA | 0 |
| NCT02703272 | Phase III | Ibrutinib Carboplatin + Dexamethasone + Etoposide + Ifosfamide + Rituximab Carboplatin + Dexamethasone + Idarubicin + Ifosfamide + Rituximab + Vincristine Sulfate | A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma | Terminated | USA | NLD | GBR | FRA | ESP | DEU | CAN | BEL | 12 |
| NCT02912754 | Phase Ib/II | Ibrutinib Ibrutinib + Ruxolitinib | Ruxolitinib Combined With Ibrutinib in Chronic Lymphocytic Leukemia Patients | Unknown status | CAN | 0 |
| NCT02351037 | Phase II | Ibrutinib Cytarabine | A Multicenter Open-Label Phase 2a Study of Ibrutinib With or Without Cytarabine in Subjects With Acute Myeloid Leukemia | Terminated | USA | 0 |
| NCT01855750 | Phase III | Ibrutinib Rituximab Cyclophosphamide + Doxorubicin + Prednisone + Vincristine Sulfate | A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma | Completed | USA | NLD | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 18 |
| NCT02910583 | Phase II | Ibrutinib Ibrutinib + Venetoclax | Ibrutinib Plus Venetoclax in Patients With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma | Completed | USA | NZL | ITA | ESP | AUS | 1 |
| NCT02406742 | Phase Ib/II | Obinutuzumab Rituximab Ibrutinib CC-122 | A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Rituximab, Ibrutinib and Obinutuzumab in Subjects With Relapsed/Refractory CLL/SLL (ENHANCE) | Completed | USA | ITA | ESP | DEU | AUT | 0 |
| NCT02315326 | Phase Ib/II | Ibrutinib | Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Patients With Refractory/Recurrent Primary Central Nervous System Lymphoma (PCNSL) and Refractory/Recurrent Secondary Central Nervous System Lymphoma (SCNSL) | Recruiting | USA | 0 |
| NCT02604511 | Phase II | Ibrutinib | Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing | Completed | USA | 0 |
| NCT02436668 | Phase II | Gemcitabine + Nab-paclitaxel Ibrutinib | Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma | Completed | USA | ITA | GBR | FRA | ESP | DEU | BEL | 1 |
| NCT02219737 | Phase I | Ibrutinib Carboplatin + Etoposide + Ifosfamide + Rituximab | Ibrutinib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma | Completed | USA | 0 |
| NCT02947347 | Phase III | Ibrutinib Ibrutinib + Rituximab | Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | CAN | BEL | AUT | AUS | 9 |
| NCT03570892 | Phase III | Lenalidomide Ibrutinib Carboplatin + Etoposide + Ifosfamide + Rituximab Carmustine + Cytarabine + Etoposide + Melphalan Cisplatin + Dexamethasone + Gemcitabine + Rituximab Cyclophosphamide + Fludarabine + Tisagenlecleucel Cisplatin + Cytarabine + Dexamethasone + Rituximab Gemcitabine + Oxaliplatin + Rituximab Bendamustine + Fludarabine + Tisagenlecleucel | Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma (BELINDA) | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUT | AUS | 8 |
| NCT04608318 | Phase III | Ibrutinib Ibrutinib + Venetoclax Obinutuzumab + Venetoclax | Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) (CLL17) | Active, not recruiting | NLD | ITA | ESP | DEU | BEL | AUT | 7 |
| NCT02824029 | Phase II | Ibrutinib | Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma | Active, not recruiting | USA | 0 |
| NCT02415608 | Phase II | Ibrutinib | Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis | Terminated | USA | 0 |
| NCT02548962 | Phase Ib/II | Ibrutinib Dexamethasone + Pomalidomide | Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma | Terminated | USA | ESP | DEU | AUS | 2 |
| NCT03229200 | FDA approved | Ibrutinib | Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib. | Enrolling by invitation | USA | NZL | ITA | GBR | FRA | ESP | CAN | AUS | 9 |
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