Therapy Detail

Therapy Name Venetoclax
Synonym
Therapy Description

Venclexta (venetoclax) is a BH3-mimetic that binds to and inhibits BCL2, resulting in increased tumor cell apoptosis (PMID: 26589495, PMID: 25048785). Venclexta (venetoclax) is FDA approved for use in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination with chemotherapy in patients 75 years old or older with newly-diagnosed acute myeloid leukemia (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Venetoclax Venclexta ABT-199|RG7601|GDC-0199 BCL2 inhibitor 15 Venclexta (venetoclax) is a BH3-mimetic that binds to and inhibits BCL2, resulting in increased tumor cell apoptosis (PMID: 26589495, PMID: 25048785). Venclexta (venetoclax) is FDA approved for use in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination with chemotherapy in patients 75 years old or older with newly-diagnosed acute myeloid leukemia (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
TP53 mutant CLL/SLL sensitive Venetoclax Guideline Actionable Venclexta (venetoclax) is indicated in the guidelines for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org). detail...
Unknown unknown CLL/SLL not applicable Venetoclax Phase I Actionable In a Phase I trial, Venclexta (venetoclax) treatment resulted in a 79% (92/116) overall response rate and 20% (23/116) complete response rate in patients with either chronic lymphocytic leukemia or small lymphocytic lymphoma (PMID: 26639348). 26639348
Unknown unknown mantle cell lymphoma not applicable Venetoclax Phase I Actionable In a Phase I trial, Venclexta (venetoclax) treatment resulted in an overall response rate of 60% (12/20, 4 complete response), with a median progression-free survival of 2.6 months, and a median overall survival of 4.3 months in patients with relapsed/refractory mantle cell lymphoma who failed BTK inhibitor therapy (EHA23, June 2018, abstract S855). detail...
IDH2 mutant acute myeloid leukemia predicted - sensitive Venetoclax Phase II Actionable In a Phase II trial, 33% (4/12) of acute myeloid leukemia patients harboring either IDH1 or IDH2 mutations responded to treatment with Venclexta (venetoclax), demonstrating a complete response or complete response with incomplete blood count recovery (PMID: 27520294). 27520294
IDH2 D76fs acute myeloid leukemia sensitive Venetoclax Phase II Actionable In a Phase II trial, an acute myeloid leukemia patient harboring IDH2 D76fs demonstrated sensitivity to treatment with Venclexta (venetoclax), achieving a complete response with incomplete blood count recovery after 24 weeks (PMID: 27520294). 27520294
Unknown unknown acute myeloid leukemia not applicable Venetoclax Phase II Actionable In a Phase II trial, treatment with Venclexta (venetoclax) resulted in a 19% (6/32) overall response rate, a 6% (2/32) complete response, and a 13% (4/32) complete response with incomplete blood count recovery in acute myeloid leukemia patients (PMID: 27520294). 27520294
TP53 loss CLL/SLL sensitive Venetoclax Guideline Actionable Venclexta (venetoclax) is indicated in the guidelines for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 loss (NCCN.org). detail...
IDH1 mutant acute myeloid leukemia predicted - sensitive Venetoclax Phase II Actionable In a Phase II trial, 33% (4/12) of acute myeloid leukemia patients harboring either IDH1 or IDH2 mutations responded to treatment with Venclexta (venetoclax), demonstrating a complete response or complete response with incomplete blood count recovery (PMID: 27520294). 27520294
Unknown unknown chronic lymphocytic leukemia not applicable Venetoclax FDA approved Actionable In a Phase II trial that supported FDA approval, Venclexta (venetoclax) treatment resulted in an overall response rate of 65% (59/91) and a median follow-up of 14 months in chronic lymphocytic leukemia patients who were refractory to or relapsed on Imbruvica (ibrutinib) therapy (PMID: 29246803; NCT02141282). 29246803
Unknown unknown chronic lymphocytic leukemia not applicable Venetoclax FDA approved Actionable In a Phase II trial that supported FDA approval, treatment with Venclexta (venetoclax) resulted in an overall response rate of 65% (59/91), median progression free-survival of 24.7 months, and median duration of response was not reached in chronic lymphocytic leukemia patients who had progressed on prior Zydelig (idelalisib) therapy (PMID: 29305552; NCT02141282). 29305552
Unknown unknown chronic lymphocytic leukemia not applicable Venetoclax FDA approved Actionable In a Phase II clinical trial, treatment with Venclexta (venetoclax) resulted in an overall response rate of 79.4% in chronic lymphocytic leukemia patients with 17p deletion (PMID: 27014415). 27014415
Clinical Trial Phase Therapies Title Recruitment Status
NCT01794520 Phase I Venetoclax Study Evaluating ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma Suspended
NCT03609593 Phase II Rituximab Bendamustine + Rituximab Venetoclax Bendamustine/Rituximab Followed by Venetoclax and Rituximab for Treatment of Chronic Lymphocytic Leukemia Not yet recruiting
NCT02966782 Phase I Azacitidine + Venetoclax Venetoclax A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) After Hypomethylating Agent-Failure Recruiting
NCT03534180 Phase II Venetoclax Venetoclax in Treating Participants With Recurrent or Refractory Mature T-Cell Lymphoma Recruiting
NCT02055820 Phase I Venetoclax Rituximab Cyclophosphamide + Doxorubicin + Prednisone + Vincristine Obinutuzumab A Safety and Pharmacokinetics Study of GDC-0199 (ABT-199) in Patients With Non-Hodgkin's Lymphoma Active, not recruiting
NCT03485547 Phase I Venetoclax Study of Venetoclax, a BCL2 Antagonist, for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Recruiting
NCT03573024 Phase II Venetoclax Azacitidine Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia Recruiting
NCT03844048 Phase III Venetoclax An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Not yet recruiting
NCT02005471 Phase III Venetoclax Bendamustine Rituximab A Study of GDC-0199 (ABT-199) Plus MabThera/Rituxan (Rituximab) Compared With Bendamustine Plus MabThera/Rituxan (Rituximab) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Active, not recruiting
NCT03319901 Phase I Cytarabine Mercaptopurine Methotrexate Cyclophosphamide Venetoclax Doxorubicin Etoposide Vincristine Venetoclax and Chemotherapy In ALL Recruiting
NCT02756611 Phase III Venetoclax A Study to Evaluate the Efficacy of Venetoclax in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) Including Those With 17p Deletion or TP53 Mutation or Those Who Have Received a Prior B-cell Receptor Inhibitor. (VENICE I) Active, not recruiting
NCT03422393 Phase I Ibrutinib + Venetoclax Venetoclax Venetoclax With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib Recruiting
NCT03236857 Phase I Venetoclax A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies Recruiting
NCT02141282 Phase II Venetoclax A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy Active, not recruiting
NCT01889186 Phase II Venetoclax A Study of the Efficacy of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia With the 17p Deletion Active, not recruiting
NCT03214562 Phase Ib/II Venetoclax Cytarabine + Filgrastim + Fludarabine + Idarubicin + Venetoclax Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive Acute Myeloid Leukemia (AML) Induction/Consolidation Therapy With FLAG-IDA in Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia (AML) Recruiting
NCT03878524 Phase I Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) Not yet recruiting