RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR
Recruiting now · Phase 4
Conditions studied: Acute Myeloid Leukemia
In brief
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).
Key facts
- Study ID
- NCT06571825
- Run by
- He Huang
- People needed
- 118
- Starts
- 2024-07-17
- Expected to finish
- 2028-02-28
- Last updated by the study team
- 2024-08-26
Who can join
Age: 60 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
- Voluntarily signed the informed consent form and can understand and comply with the study's requirements.
You may not qualify if…
- Currently has clinically active cardiovascular disease, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any class 3 or 4 heart disease according to the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within 3 months before screening;
- Other severe diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure);
- Known human immunodeficiency virus (HIV) infection or severe viral hepatitis not controlled by medication;
- Pregnant or breastfeeding women;
- Unable to understand, comply with the study protocol, or unable to sign the informed consent form.
Where it is running
- The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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