NCT06571825 RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR
| NCT ID | NCT06571825 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | He Huang |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2027-12-30 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * Diagnosed with AML according to the 2022 WHO diagnostic criteria; * Age 60-75 years; * Intermediate to high-risk AML according to the ELN criteria, AML with myelodysplasia-related changes (AML-MRC) or therapy-related AML (t-AML), or core-binding factor AML (CBF-AML) with D816 KIT mutation; or newly diagnosed hypercellular leukemia (WBC ≥ 10×10\^9/L); * Achieved CR or CR with incomplete hematologic recovery (CRi) after one to two courses of induction chemotherapy; * Have a matched related, haploidentical, or mismatched unrelated hematopoietic stem cell donor; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula); * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal (ULN), and total bilirubin ≤ 2× ULN; * Echocardiography (ECHO) showing left ventricular ejection fraction (LVEF) ≥ 50%; Expected survival \> 8 weeks; * Vo
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.