Therapy Detail

Therapy Name Ibrutinib
Synonym
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 20 EGFR Inhibitor (Pan) 43 HER2 Inhibitor 22 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).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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
Unknown unknown chronic lymphocytic leukemia not applicable Ibrutinib Phase III Actionable In a Phase III clinical trial, Imbruvica (ibrutinib) treatment resulted in a greater progression-free survival, overall survival, and response rate when compared to chlorambucil treatment in chronic lymphocytic leukemia patients aged 65 or older (PMID: 26639149). 26639149
Unknown unknown chronic lymphocytic leukemia not applicable Ibrutinib FDA approved Actionable In a Phase III trial 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). 24881631
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 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
MYD88 L265P central nervous system lymphoma sensitive Ibrutinib Phase I Actionable In a Phase I trial, two patients with primary central nervous system lymphoma each harboring MYD88 L265P demonstrated a complete response when treated with Imbruvica (ibrutinib) (PMID: 28619981). 28619981
TP53 loss CLL/SLL sensitive Ibrutinib Guideline Actionable Imbruvica (ibrutinib) is indicated in the guidelines for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 loss (NCCN.org). detail...
ERBB2 amp esophageal cancer sensitive Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, esophageal cancer cells with ERBB2 (HER2) amplification demonstrated sensitivity to Imbruvica (ibrutinib), resulting in decreased survival in culture (PMID: 28830912). 28830912
Unknown unknown mantle cell lymphoma not applicable Ibrutinib Phase II Actionable In a Phase II trial, 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
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
DNMT3A mut FLT3 exon 14 ins NPM1 mut acute myeloid leukemia predicted - sensitive Ibrutinib Preclinical - Patient cell culture Actionable In a preclinical study, co-occurrence of FLT3-ITD , DNMT3A, and NPM1 mutations correlated with sensitivity to Imbruvica (ibrutinib) in patient-derived acute myeloid leukemia samples in an ex vivo assay (PMID: 30333627). 30333627
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
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive Ibrutinib Preclinical - Cell line xenograft Actionable In a preclinical study, Imbruvica (ibrutinib) inhibited Her family receptor signaling, resulted in apoptosis and growth inhibition in ERBB2 (HER2)-positive breast cancer cell lines in culture and in cell line xenograft models (PMID: 27256378). 27256378
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
NPM1 mutant acute myeloid leukemia predicted - sensitive Ibrutinib Preclinical - Patient cell culture Actionable In a preclinical study, NPM1 mutations correlated with sensitivity to Imbruvica (ibrutinib) in patient-derived acute myeloid leukemia samples in an ex vivo assay (PMID: 30333627). 30333627
MYD88 L265P non-Hodgkin lymphoma no benefit Ibrutinib Preclinical - Pdx Actionable In a preclinical study, a non-Hodgkin lymphoma (NHL) patient derived xenograft (PDX) model harboring both CD79B Y197N and MYD88 L265P demonstrated sensitivity to Ibruvica (ibrutinib) while an NHL patient derived xenograft (PDX) model harboring only MYD88 L265P did not respond to Ibruvica (ibrutinib) (ASH 57th Annual Meeting, 2015, abstract #2759). detail...
TP53 mutant CLL/SLL sensitive Ibrutinib Guideline Actionable Imbruvica (ibrutinib) is indicated in the guidelines for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org). detail...
DNMT3A mut NPM1 mut acute myeloid leukemia predicted - sensitive Ibrutinib Preclinical - Patient cell culture Actionable In a preclinical study, co-occurrence of DNMT3A and NPM1 mutations correlated with sensitivity to Imbruvica (ibrutinib) in patient-derived acute myeloid leukemia samples in an ex vivo assay (PMID: 30333627). 30333627
MYD88 L265P diffuse large B-cell lymphoma resistant Ibrutinib Phase II Actionable In a Phase II trial, all of diffuse large B-cell lymphoma patients harboring MYD88 L265P (n=4) did not respond to Imbruvica (ibrutinib) treatment (Blood 2012, 120 (21): 686). 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...
FLT3 exon 14 ins NPM1 mutant acute myeloid leukemia predicted - sensitive Ibrutinib Preclinical - Patient cell culture Actionable In a preclinical study, co-occurrence of FLT3-ITD and NPM1 mutations correlated with sensitivity to Imbruvica (ibrutinib) in patient-derived acute myeloid leukemia samples in an ex vivo assay (PMID: 30333627). 30333627
Clinical Trial Phase Therapies Title Recruitment Status
NCT02910583 Phase II Ibrutinib Ibrutinib + Venetoclax Ibrutinib Plus Venetoclax in Patients With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma Active, not recruiting
NCT01109069 Phase II Ibrutinib Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia Active, not recruiting
NCT02352558 Phase I Imatinib Napabucasin Bortezomib Ibrutinib Dexamethasone A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies Completed
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
NCT02415608 Phase II Ibrutinib Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis Terminated
NCT02242097 Phase II Ibrutinib Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma Active, not recruiting
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
NCT02575300 Phase II Ibrutinib Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors Active, not recruiting
NCT02966730 Phase I Ibrutinib Ibrutinib for Patients With Follicular Lymphoma Without Complete Response to Initial Chemoimmunotherapy Active, not recruiting
NCT02912754 Phase Ib/II Ibrutinib Ibrutinib + Ruxolitinib Ruxolitinib Combined With Ibrutinib in Chronic Lymphocytic Leukemia Patients Not yet recruiting
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
NCT02824029 Phase II Ibrutinib Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma Recruiting
NCT02801578 Phase I Ibrutinib A Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL) Completed
NCT02947347 Phase III Ibrutinib Ibrutinib + Rituximab Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma Recruiting
NCT02943473 Phase II Ibrutinib Study on the Effect of Ibrutinib on High Risk Smoldering Multiple Myeloma Patients Recruiting
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
NCT01804686 Phase III Ibrutinib A Long-term Extension Study of PCI-32765 (Ibrutinib) Enrolling by invitation
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
NCT03282396 Phase II Ibrutinib Ibrutinib in Newly Diagnosed Mantle Cell Lymphoma With Low-Risk Disease Not yet recruiting
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) Active, not recruiting
NCT03943342 Phase II Ibrutinib Ibrutinib + Venetoclax Ibrutinib and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia After Ibrutinib Resistance Not yet recruiting
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 Suspended
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
NCT03734016 Phase III Ibrutinib BGB-3111 A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia Recruiting
NCT02129062 Phase II Ibrutinib Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Terminated
NCT03112174 Phase III Ibrutinib Ibrutinib + Venetoclax Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO) Recruiting
NCT03229200 FDA approved Ibrutinib Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib. Enrolling by invitation
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
NCT02007044 Phase II Ibrutinib Ibrutinib + Rituximab Rituximab Ibrutinib Versus Ibrutinib + Rituximab (i vs iR) in Patients With Relapsed Chronic Lymphocytic Leukemia (CLL) Active, not recruiting
NCT02649387 Phase II Ibrutinib Ibrutinib in Treating Minimal Residual Disease in Patients With Chronic Lymphocytic Leukemia After Front-Line Therapy (MERIT) Recruiting
NCT02703272 Phase III Ibrutinib Carboplatin + Dexamethasone + Etoposide + Ifosfamide + Rituximab Carboplatin + Dexamethasone + Idarubicin + Ifosfamide + Rituximab + Vincristine A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma Recruiting
NCT01841723 Phase II Ibrutinib Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia Recruiting
NCT02869633 Phase II Ibrutinib Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant Recruiting
NCT02629809 Phase II Allopurinol Cyclophosphamide + Fludarabine + Obinutuzumab Ibrutinib First-line Therapy With Ibrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (GA-101) (iFCG) for Patients With Chronic Lymphocytic Leukemia (CLL) Recruiting
NCT01974440 Phase III Ibrutinib Bendamustine + Rituximab Cyclophosphamide + Doxorubicin + Prednisone + Vincristine 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
NCT02581930 Phase II Ibrutinib Ibrutinib in Treating Patients With Refractory Stage IV Cutaneous Melanoma Active, not recruiting
NCT02272686 Phase II Ibrutinib Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma Terminated
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 Active, not recruiting
NCT02309580 Phase I Ibrutinib Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma Recruiting
NCT03207555 Phase II Ibrutinib Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL) Recruiting
NCT02643667 Phase Ib/II Ibrutinib A Study of Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer Recruiting
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
NCT03877055 Phase Ib/II Copanlisib + Ibrutinib Ibrutinib A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma Recruiting
NCT03053440 Phase III Ibrutinib BGB-3111 A Study Comparing BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM) Active, not recruiting
NCT01855750 Phase III Ibrutinib Rituximab Cyclophosphamide + Doxorubicin + Prednisone + Vincristine 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 Active, not recruiting
NCT03267186 Phase II Ibrutinib Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant Recruiting
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) Active, not recruiting
NCT02436707 Phase II Ibrutinib Cisplatin + Dexamethasone + Gemcitabine + Rituximab Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma Recruiting
NCT02207062 Phase I Ibrutinib Ibrutinib in Treating Patients With Relapsed or Refractory Transformed Indolent B-cell Non-Hodgkin Lymphoma Active, not recruiting
NCT02548962 Phase Ib/II Ibrutinib Dexamethasone + Pomalidomide Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma Terminated
NCT03219047 Phase I Ibrutinib The EXPLORE Trial: Study Evaluating Xenografts to Personalize Therapies (PDX) in Relapsed Mantle Cell Lymphoma to Optimize Response Recruiting
NCT02006485 Phase I Ublituximab + Umbralisib Ibrutinib Ublituximab in Combination With TGR-1202 in Patients With B-cell Malignancies Active, not recruiting
NCT03088878 Phase Ib/II Cirmtuzumab Cirmtuzumab + Ibrutinib Ibrutinib A Study of the Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid Malignancies Recruiting
NCT03535350 Phase I Ibrutinib Ibrutinib + Temozolomide Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Recruiting
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