OncoMatch/Clinical Trials/NCT06668558
Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia
Is NCT06668558 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Other
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.
Frequently asked questions
Is NCT06668558 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior rescue treatment for MRD disqualifies patients from enrollment.
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 qualifyRelated pages