OncoMatch/Clinical Trials/NCT06571825
RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR
Is NCT06571825 recruiting? Yes, currently enrolling (Jun 2026). This Phase 4 trial studies multiple treatments including Venetoclax and Allogeneic transplant for acute myeloid leukemia.
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 qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: KIT d816 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT06571825 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received induction chemotherapy.
Does this trial require KIT?
Yes, KIT d816 mutation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger and at least 60 years old.
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