OncoMatch/Clinical Trials/NCT04905810
Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
Is NCT04905810 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Azacitidine and Decitabine for acute myeloid leukemia.
Treatment: Azacitidine · Decitabine · Venetoclax — This phase II trial evaluates the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before (treatment naive) or has come back (relapsed). Chemotherapy drugs, such as azacitidine, decitabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hypomethylating agent (decitabine, azacitidine) — antecedent hematologic disorder
Prior decitabine and/or azacitidine, including oral formulations, for antecedent hematologic disorder is required. The patient should be treatment naïve for the AML diagnosis
Must have received: allogeneic hematopoietic transplant — antecedent hematologic disorder
Prior allogeneic hematopoietic transplant for antecedent hematologic disorder is allowed if done at least 3 months prior to enrollment and there is no evidence of active graft versus host disease (GVHD) or requirement for systemic immune suppression
Cannot have received: venetoclax (venetoclax)
Prior therapy with venetoclax
Lab requirements
Blood counts
Whole blood cell (WBC) >= 25,000/mm^3 at the start of study therapy (leukapheresis and hydroxyurea are allowed to meet this criteria)
Kidney function
Creatinine clearance >= 30 mL/min (calculated by the Cockcroft Gault formula or measured by 24-hours urine collection)
Liver function
Total bilirubin <= 1.5 x institution's ULN unless related to AML or Gilbert's syndrome (subjects who are >= 18-74 may have a total bilirubin of <= 3 x institution's ULN); AST/ALT <= 3 x institutional ULN unless related to AML
Whole blood cell (WBC) >= 25,000/mm^3 at the start of study therapy (leukapheresis and hydroxyurea are allowed to meet this criteria); Total bilirubin <= 1.5 x institution's ULN unless related to AML or Gilbert's syndrome (subjects who are >= 18-74 may have a total bilirubin of <= 3 x institution's ULN); AST/ALT <= 3 x institutional ULN unless related to AML; Creatinine clearance >= 30 mL/min (calculated by the Cockcroft Gault formula or measured by 24-hours urine collection)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCSF-Fresno · Clovis, California
- UCLA / Jonsson Comprehensive Cancer Center · Los Angeles, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
- University of Oklahoma Health Sciences Center · Oklahoma City, Oklahoma
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify