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 29 | 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 (category 1) 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 |
| NCT05782127 | Phase Ib/II | Azacitidine + Venetoclax | Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes | Active, not recruiting | FRA | 0 |
| NCT05379166 | Phase II | Azacitidine + Venetoclax | Venetoclax and Azacitidine for Treatment of Therapy Related or Secondary Myelodysplastic Syndrome | Active, not 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 | Active, not recruiting | USA | 0 |
| 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 | TUR | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | AUS | 6 |
| NCT05564390 | Phase II | Decitabine and Cedazuridine Fludarabine + Melphalan Decitabine and Cedazuridine + Enasidenib Decitabine and Cedazuridine + Olutasidenib Azacitidine + Gilteritinib + Venetoclax Decitabine and Cedazuridine + Venetoclax Cytarabine + Daunorubicin + Gemtuzumab ozogamicin CPX-351 Olutasidenib Decitabine and Cedazuridine + Enasidenib + Venetoclax Cytarabine + Venetoclax Cytarabine + Daunorubicin + Venetoclax CPX-351 + Venetoclax Cytarabine + Daunorubicin Cytarabine Azacitidine + Venetoclax Decitabine and Cedazuridine + Olutasidenib + Venetoclax | MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) | Recruiting | USA | CAN | 1 |
| 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 |
| NCT05074355 | Phase II | Azacitidine + Venetoclax | Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms | Recruiting | CAN | 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 |
| NCT04801797 | Phase II | Azacitidine + Venetoclax Cytarabine + Idarubicin Cytarabine + Daunoxome Cytarabine + Daunorubicin | Venetoclax + Azacitidine vs. Induction Chemotherapy in AML | Recruiting | USA | 0 |
| NCT06903702 | Phase II | Azacitidine + Venetoclax | A Study of Azacitidine and Venetoclax Versus a Stem Cell Transplant in People 65 Years and Older With Acute Myeloid Leukemia | Recruiting | USA | 0 |
| NCT07082452 | Phase III | Azacitidine + Venetoclax | A Multicenter Trial Evaluating Efficacy and Safety of A Reduced Venetoclax Exposure To Seven Days Versus Standard Continuous Venetoclax Exposure Combined With Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction (SEVENAZA) | Not yet recruiting | FRA | 0 |
| NCT05766514 | Phase II | Cladribine + Cytarabine + Decitabine Decitabine + Venetoclax Azacitidine + Venetoclax | Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction | Withdrawn | USA | 0 |
| NCT07060001 | Phase II | Decitabine Azacitidine Decitabine + Venetoclax Azacitidine + Venetoclax Anthracycline + Cytarabine | Efficacy of Hypomethylating Agents vs. Intensive Chemotherapy in Acute Myeloid Leukemia Using 5hmC as a Blood-Based Minimal Residual Disease Marker | Not yet recruiting | USA | 0 |
| NCT05554393 | Phase II | Cytarabine + Daunorubicin Cytarabine + Daunorubicin + Venetoclax Azacitidine + Venetoclax | Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial) | Recruiting | USA | CAN | 1 |
| NCT06557421 | Phase II | Azacitidine + Venetoclax | De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients (STOP VEN) | Recruiting | FRA | 0 |
| 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 |
| NCT06773208 | Phase II | Azacitidine + Venetoclax | A Study of Azacitidine and Venetoclax in People With Acute Myeloid Leukemia (AML) | Recruiting | USA | 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 | Terminated | USA | 0 |
| NCT06317649 | Phase II | Azacitidine + Gilteritinib + Venetoclax Azacitidine + Venetoclax | Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial) | Recruiting | USA | 1 |
| 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 | TUR | POL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUT | AUS | 6 |
| NCT06852222 | Phase III | Azacitidine + Bleximenib + Venetoclax Azacitidine + Venetoclax | A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) (cAMeLot-2) | Recruiting | USA | TUR | POL | ITA | ISR | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | 7 |
| NCT04128501 | Phase II | Azacitidine + Venetoclax | Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting | Recruiting | USA | 0 |
| NCT04062266 | Phase II | Azacitidine + Venetoclax | AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission | Active, not recruiting | USA | 0 |
| NCT07007312 | Phase III | Cytarabine + Daunorubicin Azacitidine + Venetoclax Cytarabine + Daunorubicin + Ziftomenib Azacitidine + Venetoclax + Ziftomenib | Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML | 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 |
| 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) | Terminated | USA | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | AUS | 4 |
| 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 |
| NCT05768711 | Phase II | Azacitidine + Venetoclax | Azacitidine Combined With Venetoclax in Patients With Higher-risk Chronic Myelomonocytic Leukemia (AVENHIR) (AVENHIR) | Active, not recruiting | FRA | 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 | Active, not recruiting | USA | 0 |
| NCT05079230 | Phase III | Azacitidine + Magrolimab + 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) | Terminated | USA | POL | NOR | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BEL | AUT | AUS | 3 |
| NCT03613532 | Phase I | Azacitidine + Venetoclax Busulfan + Fludarabine + Venetoclax Decitabine and Cedazuridine | Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN | 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 |
| 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 |
| 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 | TUR | SWE | POL | NOR | ITA | ISR | HUN | HRV | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | 9 |
| NCT05431257 | Phase II | Azacitidine + Venetoclax Venetoclax | Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative AML Profiling (LD-VenEx) | Recruiting | DNK | 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) | Completed | USA | AUS | 0 |
| NCT06232655 | Phase II | Cladribine + Venetoclax Azacitidine + Venetoclax | Cladribine Venetoclax in Monocytic AML | Recruiting | USA | 0 |
| NCT06158100 | Phase I | Azacitidine + Venetoclax | Venetoclax in Combination With Azacitidine (VEN/AZA) Followed by Donor Lymphocyte Infusion (DLI) for Patients With Very High-Risk Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Cell Transplant (HCT) | Suspended | USA | 0 |
| NCT06511882 | Phase II | Decitabine + Venetoclax Azacitidine + Venetoclax | Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD | 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 | Active, not recruiting | USA | 0 |
| NCT05287568 | Phase I | Azacitidine + Venetoclax | CC-486 and Venetoclax for Acute Myeloid Leukemia | Recruiting | USA | 0 |
| NCT06384261 | Phase II | Azacitidine + Cusatuzumab + Venetoclax Azacitidine + Venetoclax | A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy | Recruiting | USA | DEU | CHE | CAN | 0 |
| NCT04160052 | Phase Ib/II | Azacitidine + Venetoclax | Venetoclax and Azacitidine for the Treatment of High-Risk Recurrent or Refractory Myelodysplastic Syndrome | Active, not recruiting | USA | 0 |
| NCT04266795 | Phase II | Azacitidine + Venetoclax Azacitidine + MLN4924 + Venetoclax | A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy (PEVENAZA) | Completed | USA | POL | ITA | FRA | CAN | 0 |
| NCT05834244 | Phase I | Azacitidine + Venetoclax | A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML) | Recruiting | USA | 0 |
| NCT07177079 | Phase I | Decitabine + Venetoclax Azacitidine + Venetoclax Azacitidine + Venetoclax + Vitamin C Decitabine + Venetoclax + Vitamin C | High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (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 | Completed | USA | 0 |
| NCT05904106 | Phase II | Cytarabine Azacitidine + Venetoclax Cytarabine + Daunorubicin + Gemtuzumab ozogamicin Cytarabine + Mitoxantrone | Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML (VINCENT) | Recruiting | DEU | 0 |
| NCT06504459 | Phase II | Cladribine + Cytarabine + Venetoclax Azacitidine + Venetoclax | Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML | Recruiting | USA | 0 |
| NCT05554406 | Phase II | Cytarabine + Daunorubicin Azacitidine + Venetoclax CPX-351 Cytarabine + Daunorubicin + Venetoclax CPX-351 + Venetoclax | Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) | Recruiting | USA | CAN | 1 |
| NCT06668558 | Phase II | Venetoclax Azacitidine + Venetoclax | Venetoclax + Azacitidine in Patients with Acute Myeloid Leukemia (VERDI) | Recruiting | ESP | 0 |
| NCT04778397 | Phase III | Cytarabine + Idarubicin Azacitidine + Venetoclax Azacitidine + Magrolimab Cytarabine + Daunorubicin | Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated (ENHANCE-2) | Terminated | USA | SWE | ITA | GBR | FRA | ESP | DNK | DEU | CHE | CAN | BEL | AUT | AUS | 2 |
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