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
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...
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
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 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...
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...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02966730 Phase I Ibrutinib Ibrutinib for Patients With Follicular Lymphoma Without Complete Response to Initial Chemoimmunotherapy Terminated USA 0
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) Recruiting USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 14
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
NCT03620903 Phase II Rituximab Bortezomib Ibrutinib Efficacy of First Line B-RI for Treatment Naive Waldenstrom's Macroglobulinemia Active, not recruiting DEU 1
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
NCT02309580 Phase I Ibrutinib Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma 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
NCT01109069 Phase II Ibrutinib Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia Completed 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
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
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
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
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
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
NCT04212013 Phase III Ibrutinib Ibrutinib + Rituximab A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma Active, not recruiting USA 0
NCT03535350 Phase I Ibrutinib Ibrutinib + Temozolomide Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Active, not recruiting USA 0
NCT02643667 Phase Ib/II Ibrutinib A Study of Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer 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
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
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
NCT02007044 Phase II Ibrutinib Ibrutinib + Rituximab Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic 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 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
NCT03207555 Phase II Ibrutinib Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL) Active, not 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
NCT02943473 Phase II Ibrutinib Study on the Effect of Ibrutinib on High Risk Smoldering Multiple Myeloma Patients Terminated USA 0
NCT02006485 Phase I Ublituximab + Umbralisib Ibrutinib Ublituximab in Combination With TGR-1202 in Patients With B-cell Malignancies Completed 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 0
NCT03112174 Phase III Ibrutinib Ibrutinib + Venetoclax Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 7
NCT02581930 Phase II Ibrutinib Ibrutinib in Treating Patients With Refractory Stage IV Cutaneous Melanoma Active, not recruiting USA 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
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
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
NCT02575300 Phase II Ibrutinib Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors Completed 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
NCT02207062 Phase I Ibrutinib Ibrutinib in Treating Patients With Relapsed or Refractory Transformed Indolent B-cell Non-Hodgkin Lymphoma Completed USA 0
NCT01841723 Phase II Ibrutinib Ibrutinib in Treating Patients With Relapsed Hairy Cell 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 Completed USA | GBR | FRA | ESP | DEU | BEL | AUS 12
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
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
NCT02801578 Phase I Ibrutinib A Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL) Completed USA 0
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
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
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
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
NCT02912754 Phase Ib/II Ibrutinib Ibrutinib + Ruxolitinib Ruxolitinib Combined With Ibrutinib in Chronic Lymphocytic Leukemia Patients Unknown status CAN 0
NCT02352558 Phase I Imatinib Napabucasin Bortezomib Ibrutinib Dexamethasone A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies Completed USA 0
NCT02272686 Phase II Ibrutinib Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma Terminated USA 0
NCT03943342 Phase II Ibrutinib Ibrutinib + Venetoclax Ibrutinib and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia After Ibrutinib Resistance Withdrawn 0
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
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
NCT02129062 Phase II Ibrutinib Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Terminated 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 | GBR | CAN 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
NCT03877055 Phase Ib/II Copanlisib + Ibrutinib Ibrutinib A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma Completed USA 0
NCT03282396 Phase II Ibrutinib Ibrutinib in Treating Participants With Untreated High Risk Smoldering Mantle Cell Lymphoma 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 | NLD | GBR | FRA | ESP | DEU | CAN | BEL | AUS 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 FRA 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 | NZL | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUS 5
NCT02242097 Phase II Ibrutinib Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma Active, not recruiting 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
NCT02869633 Phase II Ibrutinib Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant 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
NCT02415608 Phase II Ibrutinib Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis Terminated USA 0
NCT02824029 Phase II Ibrutinib Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma Active, not recruiting 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
NCT05694312 Phase II Ibrutinib Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL Recruiting ITA 0


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