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 |
|---|---|---|---|---|---|---|---|
| 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 - 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 |
| 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 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... |
| 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... |
| 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 |
|---|---|---|---|---|---|---|
| NCT02912754 | Phase Ib/II | Ibrutinib Ibrutinib + Ruxolitinib | Ruxolitinib Combined With Ibrutinib in Chronic Lymphocytic Leukemia Patients | Unknown status | CAN | 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 |
| NCT03535350 | Phase I | Ibrutinib Ibrutinib + Temozolomide | Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma | 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 |
| NCT02242097 | Phase II | Ibrutinib | Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma | Active, not recruiting | USA | 0 |
| NCT03943342 | Phase II | Ibrutinib Ibrutinib + Venetoclax | Ibrutinib and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia After Ibrutinib Resistance | Withdrawn | 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 |
| 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 |
| NCT02415608 | Phase II | Ibrutinib | Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis | Terminated | 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 |
| 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 |
| 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 |
| 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 |
| NCT02352558 | Phase I | Imatinib Napabucasin Bortezomib Ibrutinib Dexamethasone | A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies | Completed | 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 | NZL | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUS | 5 |
| 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 |
| 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 |
| NCT02309580 | Phase I | Ibrutinib | Study of Ibrutinib in Relapsed and Refractory T-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 |
| 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 |
| NCT02006485 | Phase I | Ublituximab + Umbralisib Ibrutinib | Ublituximab in Combination With TGR-1202 in Patients With B-cell Malignancies | 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 |
| NCT03620903 | Phase II | Rituximab Bortezomib Ibrutinib | Efficacy of First Line B-RI for Treatment Naive Waldenstrom's Macroglobulinemia | Active, not recruiting | DEU | 1 |
| NCT02824029 | Phase II | Ibrutinib | Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin 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 |
| 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 |
| 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 |
| NCT02207062 | Phase I | Ibrutinib | Ibrutinib in Treating Patients With Relapsed or Refractory Transformed Indolent B-cell Non-Hodgkin Lymphoma | Completed | 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 |
| NCT01109069 | Phase II | Ibrutinib | Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia | Completed | USA | 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 |
| NCT03877055 | Phase Ib/II | Copanlisib + Ibrutinib Ibrutinib | A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma | 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 |
| 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 |
| NCT02869633 | Phase II | Ibrutinib | Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant | 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 |
| NCT02575300 | Phase II | Ibrutinib | Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors | Completed | 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 |
| NCT02801578 | Phase I | Ibrutinib | A Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL) | Completed | USA | 0 |
| NCT03282396 | Phase II | Ibrutinib | Ibrutinib in Treating Participants With Untreated High Risk Smoldering Mantle Cell Lymphoma | Active, not recruiting | USA | 0 |
| NCT03207555 | Phase II | Ibrutinib | Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL) | Active, not recruiting | USA | 0 |
| NCT02272686 | Phase II | Ibrutinib | Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma | Terminated | 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 |
| NCT02643667 | Phase Ib/II | Ibrutinib | A Study of Ibrutinib as Neoadjuvant Therapy in Localized Prostate 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 |
| NCT05963074 | Phase II | Ibrutinib Ibrutinib + Venetoclax | A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia (TAILOR) | Recruiting | USA | ESP | 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 |
| 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 |
| 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 | 5 |
| 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 |
| NCT03267186 | Phase II | Ibrutinib | Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant | Completed | USA | 0 |
| NCT01841723 | Phase II | Ibrutinib | Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia | 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 |
| NCT05694312 | Phase II | Ibrutinib | Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL | Recruiting | ITA | 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 |
| NCT02129062 | Phase II | Ibrutinib | Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia | Terminated | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT03734016 | Phase III | Ibrutinib Zanubrutinib | A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia | Completed | 1 | |
| 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 |
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