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|Onureg 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 and Onureg (azacitidine) is FDA approved for use in continued treatment of acute myeloid leukemia(FDA.gov).
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
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...
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...
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...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03466294 Phase II Azacitidine + Venetoclax Azacitidine and Venetoclax as Induction Therapy With Venetoclax Maintenance in the Elderly With AML Active, not recruiting USA 0
NCT05834244 Phase I Azacitidine + Venetoclax A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML) Not yet recruiting USA 0
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 Active, not recruiting USA 0
NCT04266795 Phase II Azacitidine + Venetoclax Azacitidine + MLN4924 + Venetoclax Triple Combination of Pevonedistat and Venetoclax Plus Azacitidine in Adults With Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy Active, not recruiting USA | ITA | FRA | CAN 1
NCT04778397 Phase III Cytarabine + Idarubicin Azacitidine + Venetoclax Azacitidine + Hu5F9-G4 Cytarabine + Daunorubicin Study to Evaluate the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Adults With TP53 Mutant Acute Myeloid Leukemia (ENHANCE-2) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 5
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) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS 13
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) Active, not recruiting USA | ITA | GBR | FRA | DEU | CAN | AUS 0
NCT05287568 Phase I Azacitidine + Venetoclax CC-486 and Venetoclax for Acute Myeloid Leukemia Recruiting USA 0
NCT04550442 Phase Ib/II Azacitidine + Venetoclax Venetoclax and Azacitidine for the Treatment of Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia Recruiting USA 0
NCT05379166 Phase II Azacitidine + Venetoclax Venetoclax and Azacitidine for Treatment of Therapy Related or Secondary Myelodysplastic Syndrome Recruiting USA 0
NCT05079230 Phase III Azacitidine + Hu5F9-G4 + Venetoclax Azacitidine + Venetoclax Study Evaluating the Safety and Effectiveness Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia (AML) (ENHANCE-3) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 10
NCT05782127 Phase Ib/II Azacitidine + Venetoclax Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes Not yet recruiting FRA 0
NCT05365035 Phase II Azacitidine + Venetoclax Cladribine + Cytarabine + Venetoclax A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts Recruiting USA 0
NCT02203773 Phase I Decitabine + Venetoclax Azacitidine + Venetoclax Phase 1b Acute Myelogenous Leukemia (AML) Study With ABT-199 + Decitabine or Azacitidine (Chemo Combo) Terminated USA | FRA | DEU | AUS 0
NCT05074355 Phase II Azacitidine + Venetoclax Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms Not yet recruiting CAN 0
NCT05768711 Phase II Azacitidine + Venetoclax Azacitidine Combined With Venetoclax in Patients With Higher-risk Chronic Myelomonocytic Leukemia (AVENHIR) (AVENHIR) Not yet recruiting FRA 0
NCT04128501 Phase II Azacitidine + Venetoclax Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting Recruiting USA 0
NCT03926624 Phase III Decitabine + Venetoclax Azacitidine + Venetoclax Cytarabine + Filgrastim + Fludarabine + Idarubicin Cytarabine + Venetoclax Cytarabine + Filgrastim + Fludarabine Decitabine Azacitidine Cladribine + Cytarabine + Filgrastim + Mitoxantrone DFP-10917 Cladribine + Cytarabine + Filgrastim + Idarubicin Cytarabine Cytarabine + Etoposide + Mitoxantrone Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage Recruiting USA 0
NCT04160052 Phase Ib/II Azacitidine + Venetoclax Venetoclax and Azacitidine for the Treatment of High-Risk Recurrent or Refractory Myelodysplastic Syndrome Recruiting USA 0
NCT04284787 Phase II Azacitidine + Pembrolizumab + Venetoclax Azacitidine + Venetoclax BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia Suspended USA 0
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 Completed USA 0
NCT04887857 Phase I Azacitidine + Venetoclax A Study to Assess Safety and Tolerability of CC-486 (ONUREG, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML) (OMNIVERSE) Active, not recruiting USA | AUS 0
NCT04722601 Phase Ib/II Azacitidine + Venetoclax Azacitidine + Obinutuzumab + Venetoclax Obinutuzumab A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma Active, not recruiting USA 0
NCT04748848 Phase Ib/II Azacitidine + Venetoclax Azacitidine + CC-90011 + Venetoclax A Safety, Tolerability and Preliminary Efficacy Study of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia and Treatment-naïve Participants Not Eligible for Intensive Therapy Terminated USA | FRA | ESP | BEL 0
NCT05292664 Phase I Azacitidine + Cytarabine + Hydrocortisone + Leucovorin + Methotrexate + Venetoclax Calaspargase pegol-mknl + Cytarabine + Dexamethasone + Dexrazoxane + Doxorubicin + Hydrocortisone + Leucovorin + Methotrexate + Venetoclax + Vincristine Sulfate Azacitidine + Venetoclax Venetoclax Basket Trial for High Risk Hematologic Malignancies Recruiting USA 0
NCT04801797 Phase II Azacitidine + Venetoclax Cytarabine + Idarubicin Cytarabine + Daunoxome Cytarabine + Daunorubicin Venetoclax + Azacitidine vs. Induction Chemotherapy in AML Recruiting USA 0
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) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 13
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 USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS 10
NCT04062266 Phase II Azacitidine + Venetoclax AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission Recruiting USA 0
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
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 USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | AUS 20


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