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 approved for mantle cell lymphoma and first line treatment of chronic lymphocytic leukemia (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Ibrutinib Imbruvica PCI-32765 BTK inhibitor 26 EGFR Inhibitor (Pan) 50 HER2 Inhibitor 29 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
TP53 mutant CLL/SLL 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...
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 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
TP53 loss CLL/SLL 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...
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
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03943342 Phase II Ibrutinib Ibrutinib + Venetoclax Ibrutinib and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia After Ibrutinib Resistance Withdrawn 0
NCT04665115 Phase II Ibrutinib Ibrutinib for the Treatment of Patients With B-Cell Malignancies Who Are Infected With Coronavirus Disease 2019 (COVID-19) Not yet recruiting USA 0
NCT02272686 Phase II Ibrutinib Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma Terminated USA 0
NCT02869633 Phase II Ibrutinib Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant 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 Completed USA | CAN 18
NCT02581930 Phase II Ibrutinib Ibrutinib in Treating Patients With Refractory Stage IV Cutaneous Melanoma Active, not recruiting USA 0
NCT03229200 FDA approved Ibrutinib Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib. Enrolling by invitation USA | CAN 15
NCT01804686 Phase III Ibrutinib A Long-term Extension Study of PCI-32765 (Ibrutinib) Enrolling by invitation USA | CAN 27
NCT03267186 Phase II Ibrutinib Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant Active, not recruiting USA 0
NCT02912754 Phase Ib/II Ibrutinib Ibrutinib + Ruxolitinib Ruxolitinib Combined With Ibrutinib in Chronic Lymphocytic Leukemia Patients Unknown status CAN 0
NCT03088878 Phase Ib/II Cirmtuzumab Cirmtuzumab + Ibrutinib Ibrutinib A Study of the Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid Malignancies Recruiting USA 0
NCT02575300 Phase II Ibrutinib Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors Completed USA 0
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
NCT03219047 Phase I Ibrutinib The EXPLORE Trial: Study Evaluating Xenografts to Personalize Therapies (PDX) in Relapsed Mantle Cell Lymphoma to Optimize Response Recruiting USA 0
NCT02007044 Phase II Ibrutinib Ibrutinib + Rituximab Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia Active, not recruiting USA 0
NCT03053440 Phase III Ibrutinib Zanubrutinib A Study Comparing BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM) Active, not recruiting USA 12
NCT03282396 Phase II Ibrutinib Ibrutinib in Treating Participants With Untreated High Risk Smoldering Mantle Cell Lymphoma Recruiting USA 0
NCT02006485 Phase I Ublituximab + Umbralisib Ibrutinib Ublituximab in Combination With TGR-1202 in Patients With B-cell Malignancies Completed USA 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
NCT02943473 Phase II Ibrutinib Study on the Effect of Ibrutinib on High Risk Smoldering Multiple Myeloma Patients Terminated USA 0
NCT02207062 Phase I Ibrutinib Ibrutinib in Treating Patients With Relapsed or Refractory Transformed Indolent B-cell Non-Hodgkin Lymphoma Active, not recruiting USA 0
NCT01841723 Phase II Ibrutinib Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia Active, not 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 Active, not recruiting USA 0
NCT02947347 Phase III Ibrutinib Ibrutinib + Rituximab Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma Active, not recruiting USA | CAN 18
NCT04212013 Phase III Ibrutinib Ibrutinib + Rituximab A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma Recruiting USA 0
NCT02415608 Phase II Ibrutinib Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis Terminated USA 0
NCT02801578 Phase I Ibrutinib A Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL) Completed USA 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
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 0
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) Recruiting 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
NCT02824029 Phase II Ibrutinib Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma Active, not recruiting 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 5
NCT03112174 Phase III Ibrutinib Ibrutinib + Venetoclax Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO) Active, not recruiting USA | CAN 15
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 17
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
NCT02352558 Phase I Imatinib Napabucasin Bortezomib Ibrutinib Dexamethasone A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies Completed 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 Recruiting 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 7
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 4
NCT02309580 Phase I Ibrutinib Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma Recruiting USA 0
NCT03207555 Phase II Ibrutinib Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL) Recruiting USA 0
NCT01109069 Phase II Ibrutinib Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia 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
NCT03535350 Phase I Ibrutinib Ibrutinib + Temozolomide Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Recruiting USA 0
NCT02643667 Phase Ib/II Ibrutinib A Study of Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer Recruiting USA 0
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 Active, not recruiting USA 18
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 1
NCT02910583 Phase II Ibrutinib Ibrutinib + Venetoclax Ibrutinib Plus Venetoclax in Patients With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma Active, not recruiting USA 4
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 Active, not recruiting USA 14
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
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 | CAN 25
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 Recruiting USA 1
NCT04802590 Phase II Ibrutinib Ibrutinib + Venetoclax Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma Not yet recruiting 2
NCT02242097 Phase II Ibrutinib Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma Active, not recruiting USA 0
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 14
NCT02966730 Phase I Ibrutinib Ibrutinib for Patients With Follicular Lymphoma Without Complete Response to Initial Chemoimmunotherapy Terminated USA 0
NCT02129062 Phase II Ibrutinib Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Terminated USA 0
NCT03877055 Phase Ib/II Copanlisib + Ibrutinib Ibrutinib A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma Active, not recruiting USA 0
NCT04662255 Phase III Ibrutinib Zanubrutinib LOXO-305 Acalabrutinib Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321) Recruiting USA 15


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