OncoMatch/Clinical Trials/NCT06668558
Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia
Is NCT06668558 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Azacitidine (AZA) and Venetoclax for acute myeloid leukemia.
Treatment: Azacitidine (AZA) · Venetoclax — The VERDI study is an investigator-initiated, multicenter, multicohort, phase II trial with combination of venetoclax + azacitidine for patients treated for AML under according to an intensive chemotherapy protocol (CETLAM-20) failing to achieve or maintain MRD negativity at pre-established time-points: at chemotherapy completion for ELN favorable subtypes, and prior to alloHCT for non-favorable European LeukemiaNet (ELN) AML patients. The primary objective is to determine Ven/Aza treatment activity in MRD clearance in patients diagnosed with AML with persistent MRD or MRD reappearance after frontline chemotherapy, or prior to alloHCT.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Allowed: NPM1 mutation
In patients with NPM1 mutation, qRT-PCR of NPM1 will be the method used to establish a molecular failure, defined as failure to achieve molecular response after consolidation therapy (NPM1mut/ABL1·100 > 0.1) or MRD reappearance after molecular response.
Allowed: RUNX1 RUNX1-RUNX1T1 fusion
In patients with core-binding factor AML, qRT-BCR of RUNX1-RUNX1T1 and CBFb-MYH11 transcripts will be used.
Allowed: CBFB CBFb-MYH11 fusion
In patients with core-binding factor AML, qRT-BCR of RUNX1-RUNX1T1 and CBFb-MYH11 transcripts will be used.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cytarabine (cytarabine) — frontline intensive chemotherapy
frontline intensive chemotherapy (including at least one cycle of cytarabine and anthracycline)
Must have received: anthracycline (anthracycline) — frontline intensive chemotherapy
frontline intensive chemotherapy (including at least one cycle of cytarabine and anthracycline)
Cannot have received: rescue treatment for MRD
Patient has received other prior rescue treatment for MRD.
Lab requirements
Kidney function
creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula
Liver function
AST ≤ 3.0 × ULN; ALT ≤ 3.0 × ULN; bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome
adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; adequate liver function as demonstrated by: AST ≤ 3.0 × ULN; ALT ≤ 3.0 × ULN; bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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