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

He Huang

Status and phase

Enrolling

Phase 4

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Allogeneic transplant

Drug: Venetoclax

Study type

Interventional

Funder types

Other

Identifiers

NCT06571825

TROPHY-AML03

Details and patient eligibility

About

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).

Enrollment

118 estimated patients

Sex

All

Ages

60 to 75 years old

Volunteers

No Healthy Volunteers

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;
Voluntarily signed the informed consent form and can understand and comply with the study's requirements.

Exclusion criteria

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.