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 25 EGFR Inhibitor (Pan) 47 HER2 Inhibitor 26 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
Unknown unknown mantle cell lymphoma not applicable Ibrutinib FDA approved Actionable In a Phase II trial (Study 1104) that supported FDA approval, Imbruvica (ibrutinib) treatment resulted in a response rate of 68% (75/111, complete response 21%, partial response 47%), with an estimated median progression-free survival of 13.9 months in patients with relapsed or refractory mantle-cell lymphoma (PMID: 23782157, NCT01236391). 23782157 detail...
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 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
Unknown unknown acute myeloid leukemia not applicable Ibrutinib Preclinical - Patient cell culture Actionable In a preclinical study, Imbruvica (ibrutinib) treatment reduced viability of patient-derived acute myeloid leukemia cells, however, with decreased response compared to cells treated with Abivertinib (AC0010) in culture (PMID: 31310800). 31310800
Unknown unknown hairy cell leukemia not applicable Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, Imbruvica (ibrutinib) inhibited Btk activity and B-cell receptor signaling, thereby resulting in inhibition of cell proliferation and decreased survival of human hairy cell leukemia cells in culture (PMID: 24697238). 24697238
Unknown unknown Waldenstroem's macroglobulinemia not applicable Ibrutinib FDA approved Actionable In a Phase II trial that supported FDA approval, Ibruvica (ibrutinib) treatment resulted in an overall response rate of 90.5% and a major response rate of 73.0% in patients with previously treated Waldenstroem's macroglobulinemia (PMID: 25853747; NCT01614821). 25853747 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
Unknown unknown CLL/SLL not applicable Ibrutinib FDA approved Actionable In a Phase III trial (RESONATE) that supported FDA approval, treatment with Imbruvica (ibrutinib) in chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL) patients with del 17p resulted in improved progression-free survival compared to Arzerra (ofatumumab) (40.6 vs. 8.1 months), and improved overall response rate (47.6%, 30/63 vs 4.7%, 3/64) (PMID: 31512258; NCT01578707). 31512258 detail...
Unknown unknown CLL/SLL not applicable Ibrutinib FDA approved Actionable In a Phase III trial (RESONATE-2) that supported FDA approval, Imbruvica (ibrutinib) treatment resulted in a greater median progression-free survival (not reached vs 18.9 months, HR=0.16, p<0.001) and response rate (86% vs 35%, p<0.001) when compared to chlorambucil treatment in patients with chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL) aged 65 or older (PMID: 26639149; NCT01722487). detail... 26639149
Unknown unknown CLL/SLL not applicable Ibrutinib FDA approved Actionable In a Phase III trial (RESONATE) that supported FDA approval, treatment with Imbruvica (ibrutinib) in chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL) patients resulted in improved progression-free survival compared to treatment with Arzerra (ofatumumab) (median duration not reached vs. 8.1 months), and an overall response rate of 43% (83/195) versus 4% (8/196) with Arzerra (ofatumumab) (PMID: 24881631; NCT01578707). detail... 24881631
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...
Unknown unknown central nervous system lymphoma not applicable Ibrutinib Phase I Actionable In a Phase I trial, Imbruvica (ibrutinib) treatment resulted in antitumor efficacy in 77% (10/13) of patients with primary central nervous system lymphoma, demonstrating a complete response in five patients and a partial response in five patients (PMID: 28619981). 28619981
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
Unknown unknown chronic lymphocytic leukemia not applicable Ibrutinib Clinical Study Actionable In a clinical study, treatment with Imbruvica (ibrutinib) resulted in a discontinuation-free survival rate at 1 year of 73.7% (232/315) and an absolute 1 year survival rate of 83.3% (264/315) in patients with relapsed or refractory chronic lymphocytic leukemia (PMID: 27756834). 27756834
Unknown unknown marginal zone B-cell lymphoma not applicable Ibrutinib FDA approved Actionable In a Phase II trial that supported FDA approval, Imbruvica (ibrutinib) treatment resulted in an objective response rate of 48% (29/60) in patients with previously treated marginal zone lymphoma, with a median progression-free survival of 14.2 months (PMID: 28167659; NCT01980628). 28167659 detail...
Unknown unknown diffuse large B-cell lymphoma not applicable Ibrutinib Phase II Actionable In a Phase II trial, Imbruvica (ibrutinib) treatment demonstrated preferential efficacy in the ABC subtype of diffuse large B-cell lymphoma (DLBCL) compared to the GCB subtype, resulted in complete response in 8% (2/25) and partial response in 32% (8/25) of ABC DLBCL patients, but only partial response in 5.3% (1/19) of GCB DLBCL patients (Blood 2012, 120 (21): 686). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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) Recruiting USA 17
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
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
NCT03535350 Phase I Ibrutinib Ibrutinib + Temozolomide Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Recruiting USA 0
NCT03229200 FDA approved Ibrutinib Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib. Enrolling by invitation USA | CAN 15
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
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
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
NCT03112174 Phase III Ibrutinib Ibrutinib + Venetoclax Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO) Recruiting USA | CAN 15
NCT02912754 Phase Ib/II Ibrutinib Ibrutinib + Ruxolitinib Ruxolitinib Combined With Ibrutinib in Chronic Lymphocytic Leukemia Patients Unknown status CAN 0
NCT03943342 Phase II Ibrutinib Ibrutinib + Venetoclax Ibrutinib and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia After Ibrutinib Resistance Recruiting USA 0
NCT01804686 Phase III Ibrutinib A Long-term Extension Study of PCI-32765 (Ibrutinib) Enrolling by invitation USA | CAN 27
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 Active, not recruiting USA | CAN 18
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
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
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
NCT02643667 Phase Ib/II Ibrutinib A Study of Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer Recruiting USA 0
NCT03267186 Phase II Ibrutinib Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant Active, not recruiting USA 0
NCT02824029 Phase II Ibrutinib Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma Recruiting 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 Recruiting USA 1
NCT03877055 Phase Ib/II Copanlisib + Ibrutinib Ibrutinib A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma Active, not recruiting USA 0
NCT02242097 Phase II Ibrutinib Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma Active, not recruiting USA 0
NCT02581930 Phase II Ibrutinib Ibrutinib in Treating Patients With Refractory Stage IV Cutaneous Melanoma Active, not recruiting USA 0
NCT03207555 Phase II Ibrutinib Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL) Recruiting USA 0
NCT02801578 Phase I Ibrutinib A Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL) Completed 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
NCT04802590 Phase II Ibrutinib Ibrutinib + Venetoclax Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma Not yet recruiting 2
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
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
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
NCT02415608 Phase II Ibrutinib Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis Terminated USA 0
NCT02943473 Phase II Ibrutinib Study on the Effect of Ibrutinib on High Risk Smoldering Multiple Myeloma Patients Terminated 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
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 Active, not recruiting USA 0
NCT02947347 Phase III Ibrutinib Ibrutinib + Rituximab Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma Recruiting USA | CAN 18
NCT02309580 Phase I Ibrutinib Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma Recruiting USA 0
NCT04212013 Phase III Ibrutinib Ibrutinib + Rituximab A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma Recruiting 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
NCT02869633 Phase II Ibrutinib Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant Active, not recruiting 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
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
NCT02352558 Phase I Imatinib Napabucasin Bortezomib Ibrutinib Dexamethasone A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies Completed 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 | CAN 6
NCT02007044 Phase II Ibrutinib Ibrutinib + Rituximab Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia Active, not 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
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
NCT03053440 Phase III Ibrutinib Zanubrutinib A Study Comparing BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM) Active, not recruiting USA 12
NCT02207062 Phase I Ibrutinib Ibrutinib in Treating Patients With Relapsed or Refractory Transformed Indolent B-cell Non-Hodgkin Lymphoma Active, not recruiting USA 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
NCT02006485 Phase I Ublituximab + Umbralisib Ibrutinib Ublituximab in Combination With TGR-1202 in Patients With B-cell Malignancies 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) Active, not 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
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
NCT02272686 Phase II Ibrutinib Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma Terminated USA 0
NCT02575300 Phase II Ibrutinib Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors Completed USA 0
NCT03282396 Phase II Ibrutinib Ibrutinib in Treating Participants With Untreated High Risk Smoldering Mantle Cell Lymphoma 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
NCT01841723 Phase II Ibrutinib Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia Recruiting USA 0


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