Clinical Trial

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

Recruiting Phase 4
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Summary
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).
Trial Details
NCT Number NCT06571825
Lead Sponsor He Huang
Conditions Acute Myeloid Leukemia
Enrollment 118 participants
Start Date 2024-07-17
Primary Completion 2027-12-30 (estimated)
Study Completion 2028-02-28 (estimated)
Updated on ClinicalTrials.gov 2024-08-26