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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60-75
SponsorHe Huang

About this trial

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

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Venetoclax
  • Allogeneic transplant

Treatment groups

118 Participants
are divided into 2 treatment groups

Sponsors and collaborators

He Huang

Lead sponsor

Zhejiang University

Sponsor institution