OncoMatch/Clinical Trials/NCT06571825

RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR

Is NCT06571825 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Venetoclax and Allogeneic transplant for acute myeloid leukemia.

Phase 4RecruitingHe HuangNCT06571825Data as of May 2026

Treatment: Venetoclax · Allogeneic transplant — Elderly patients with acute myeloid leukemia (AML) often face unfavorable prognostic factors such as multiple comorbidities, adverse cytogenetic profiles, and pre-existing hematological disorders. The long-term survival rate remains very low, with a 5-year survival rate of only 5% to 10%. The introduction of the BCL-2 inhibitor venetoclax (Ven) has improved the induction remission rates in elderly patients. However, the question of whether to use chemotherapy maintenance or proceed with allogeneic hematopoietic stem cell transplantation (allo-HSCT) for post-remission consolidation therapy remains unclear due to the lack of prospective controlled studies. Therefore, our center plans to conduct a prospective, open-label, two-arm, non-randomized, single-center study to further explore the optimal consolidation treatment strategy for elderly AML patients at intermediate and high risk following induction complete remission (CR).

Check if I qualify

Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: KIT d816 mutation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 2 prior lines

Min 1 prior line

Must have received: induction chemotherapy

Achieved CR or CR with incomplete hematologic recovery (CRi) after one to two courses of induction chemotherapy

Lab requirements

Kidney function

Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)

Liver function

AST and ALT ≤ 3× ULN, total bilirubin ≤ 2× ULN

Cardiac function

ECHO showing LVEF ≥ 50%

Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula); AST and ALT ≤ 3× ULN, and total bilirubin ≤ 2× ULN; Echocardiography (ECHO) showing left ventricular ejection fraction (LVEF) ≥ 50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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