Therapy Detail

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Therapy Name Azacitidine + Venetoclax
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Azacitidine Vidaza azacytidine|CC-486|5-azacytidine|5-AC|U-18496 DNMT inhibitor (Pan) 5 Vidaza (azacitidine) is a cytidine analog that incorporates into DNA and RNA and binds to DNA methyltransferases (DNMTs), resulting in DNMT degradation and decreased DNA methylation, and leading to increased tumor cell death (PMID: 28159832, PMID: 28067760). Vidaza (azacitidine) is FDA-approved for use in patients with some subtypes of myelodysplastic syndrome (FDA.gov).
Venetoclax Venclexta ABT-199|RG7601|GDC-0199|ABT119 BCL2 inhibitor 17 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
IDH1 mutant acute myeloid leukemia sensitive Azacitidine + Venetoclax Guideline Actionable Venclexta (venetoclax) in combination with Vidaza (azacitidine) is included in guidelines for adult patients with acute myeloid leukemia harboring an IDH1 mutation (NCCN.org). detail...
Unknown unknown acute myeloid leukemia not applicable Azacitidine + Venetoclax FDA approved Actionable In a Phase I/II trial that supported FDA approval, Venclexta (venetoclax) in combination with decitabine or azacitidine resulted in complete remission or complete remission with incomplete count recovery in 65% (40/62) of patients 75 years old or older with treatment-naive acute myeloid leukemia ineligible for intensive chemotherapy, with an overall survival of 11 months (PMID: 30361262; NCT02203773). detail... 30361262
FLT3 mutant acute myeloid leukemia sensitive Azacitidine + Venetoclax Guideline Actionable Venclexta (venetoclax) in combination with Vidaza (azacitidine) is included in guidelines for adult patients with acute myeloid leukemia harboring a FLT3 mutation (NCCN.org). detail...
IDH2 mutant acute myeloid leukemia sensitive Azacitidine + Venetoclax Guideline Actionable Venclexta (venetoclax) in combination with Vidaza (azacitidine) is included in guidelines for adult patients with acute myeloid leukemia harboring an IDH2 mutation (NCCN.org). detail...

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Clinical Trial Phase Therapies Title Recruitment Status
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 Active, not recruiting
NCT03226418 Phase II Cytarabine Decitabine + Venetoclax Azacitidine + Venetoclax CPX-351 Cytarabine + Idarubicin Azacitidine + Glasdegib Decitabine + Glasdegib Cytarabine, Idarubicin, Liposome-encapsulated Daunorubicin-Cytarabine or Decitabine in Treating Older Patients With Acute Myeloid Leukemia Recruiting
NCT03941964 Phase III Decitabine + Venetoclax Azacitidine + Venetoclax A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Recruiting
NCT04401748 Phase III Azacitidine + Venetoclax Azacitidine Safety And Efficacy Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Complete Remission and Overall Survival In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome (Verona) Not yet recruiting
NCT04128501 Phase II Azacitidine + Venetoclax Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting Recruiting
NCT04161885 Phase III Azacitidine + Venetoclax A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML) (VIALE-T) Recruiting
NCT04160052 Phase Ib/II Azacitidine + Venetoclax Venetoclax and Azacitidine for the Treatment of High-Risk Recurrent or Refractory Myelodysplastic Syndrome Recruiting
NCT04062266 Phase II Azacitidine + Venetoclax Azacitidine and Venetoclax in Treating Patients With High Risk Acute Myeloid Leukemia in Remission Recruiting
NCT02993523 Phase III Azacitidine + Venetoclax Azacitidine A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Elderly Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy Active, not recruiting
NCT04102020 Phase III Azacitidine + Venetoclax A Safety and Efficacy Study of Oral Venetoclax Tablets and Injectable Azacitidine Versus Best Supportive Care as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy to Evaluate Improvement in Relapse-Free Survival (VIALE-M) Recruiting
NCT02203773 Phase I Decitabine + Venetoclax Azacitidine + Venetoclax Phase 1b Acute Myelogenous Leukemia (AML) Study With ABT-199 + Decitabine or Azacitidine (Chemo Combo) Active, not recruiting
NCT03466294 Phase II Azacitidine + Venetoclax Azacitidine and Venetoclax as Induction Therapy With Venetoclax Maintenance in the Elderly With AML Recruiting
NCT02942290 Phase II Azacitidine Azacitidine + Venetoclax A Study Evaluating Venetoclax in Combination With Azacitidine Compared With Azacitidine Alone in Participants With Previously Untreated Higher-Risk Myelodysplastic Syndromes (MDS) Recruiting


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