Therapy Detail

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Therapy Name Venetoclax
Synonyms
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|ABT119|Venclyxto BCL2 inhibitor 26 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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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
TP53 mutant chronic lymphocytic leukemia/small lymphocytic lymphoma sensitive Venetoclax Guideline Actionable Venclexta (venetoclax) is indicated in the guidelines as second line and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org). detail...
TP53 loss chronic lymphocytic leukemia/small lymphocytic lymphoma sensitive Venetoclax Guideline Actionable Venclexta (venetoclax) is indicated in the guidelines as second line and subsequent therapy 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
IDH2 D76fs acute myeloid leukemia sensitive Venetoclax Case Reports/Case Series 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
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
TP53 mutant chronic lymphocytic leukemia sensitive Venetoclax Guideline Actionable Venclexta (venetoclax) 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). detail... 33091559

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03609593 Phase II Rituximab Bendamustine + Rituximab Venetoclax Bendamustine/Rituximab Followed by Venetoclax and Rituximab for Treatment of Chronic Lymphocytic Leukemia Active, not recruiting USA 0
NCT05701215 Phase II Venetoclax Venetoclax After TKI to Target Persisting Stem Cells in CML (VARIANT) Recruiting DEU 0
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) Active, not recruiting USA 0
NCT05268003 Phase II Ponatinib Venetoclax A Phase II Study of the Combination of Ponatinib With Mini-hyper CVD Chemotherapy and Venetoclax in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia Recruiting USA 0
NCT05360160 Phase Ib/II Decitabine and Cedazuridine Revumenib Venetoclax A Phase I-II Study Investigating the All Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE) Recruiting USA 0
NCT03534180 Phase II Venetoclax Venetoclax in Treating Participants With Recurrent or Refractory Mature T-Cell Lymphoma Completed USA 0
NCT02966756 Phase II Venetoclax A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Recruiting AUS 3
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 Completed USA | DEU | AUS 0
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 USA 0
NCT03844048 Phase III Venetoclax An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Enrolling by invitation USA | GBR | FRA | ESP | CAN | BEL | AUT | AUS 15
NCT04229979 Phase III Galinpepimut-S Cytarabine Decitabine Venetoclax Azacitidine Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (REGAL) Recruiting USA | FRA | ESP | DEU 6
NCT03319901 Phase I Cytarabine Mercaptopurine Methotrexate Cyclophosphamide Venetoclax Doxorubicin Etoposide Vincristine Sulfate Venetoclax and Chemotherapy In ALL Recruiting USA 0
NCT04171791 Phase I Venetoclax A Study of ABT-199 (Venetoclax) for Cutaneous T Cell Lymphoma (CTCL) Completed USA 0
NCT05386576 Phase I Venetoclax A Study of Venetoclax in Combination With Chemotherapy to Treat Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) Recruiting USA 0
NCT03455504 Phase II Venetoclax Venetoclax Add in Combination With Fludarabine, Cyratabine and Idarubicine in Induction for Acute Myelid Leukemia (V-FIRST) Active, not recruiting ITA 0
NCT01794520 Phase I Venetoclax Study Evaluating ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma Completed USA | FRA | BEL 1
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) Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT 12
NCT03573024 Phase II Venetoclax Azacitidine Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia Recruiting USA 0
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 Completed USA 0
NCT03766763 Phase II Venetoclax Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A Recruiting FRA 0
NCT04419519 Phase II Venetoclax Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax Recruiting USA 0
NCT04070768 Phase I Gemtuzumab ozogamicin + Venetoclax Venetoclax Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113 Recruiting USA 0
NCT03485547 Phase I Venetoclax Study of Venetoclax, a BCL2 Antagonist, for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Active, not recruiting USA 0
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 Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 10
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 Completed USA | GBR | FRA | DEU | CAN | AUS 1
NCT03236857 Phase I Venetoclax A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies Completed USA | GBR | FRA | DEU | CAN | AUS 2
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 Active, not recruiting USA 0
NCT02055820 Phase I Venetoclax Rituximab Cyclophosphamide + Doxorubicin + Prednisone + Vincristine Sulfate Obinutuzumab A Safety and Pharmacokinetics Study of GDC-0199 (ABT-199) in Patients With Non-Hodgkin's Lymphoma Completed USA | ITA | FRA | ESP | CAN | AUT | AUS 3
NCT03986034 Phase II Venetoclax Early Clonal Dynamics During Venetoclax Treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Recruiting USA 0


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