About this trial
Elderly AML patients receiving conventional chemotherapy have poor prognosis. Allo-HSCT offers better long-term survival than chemotherapy, while high TRM limits its use. Current research focuses more on improving conditioning regimens to reduce TRM. Studies suggest Bu/Flu/Cy/ATG are safer and more effective for elderly AML haplo-HSCT, lowering TRM. However, prospective randomized trials are lacking. This study aims to compare Bu/Flu/Cy/ATG vs. Bu/Cy/ATG to determine if TRM can be reduced in elderly AML undergoing haplo-HSCT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
(a) Uncontrolled active infection. (b) Secondary AML. (c)Refusal to provide informed consent.
Trial design
Single group
Treatments tested in this trial
Bu/Flu/Cy/ATG
Procedure/SurgeryThe Bu/Flu/Cy/ATG conditioning regimen consists of the following components: Ara-C (2 g/m²/day, injected i.v.) on days-10 and-9; Bu (0.8 mg/kg, q6h, injected i.v.) on days -8 to -6; Flu (30 mg/m²/day, injected i.v.) from day-6 to day-2; Cy (1.0 g/m²/day, injected i.v.) on days-5 and-4; and ATG (2.5 mg/kg/day) on days-5 to -2.
Bu/Cy/ATG
Procedure/SurgeryThe Bu/Cy/ATG conditioning regimen consists of the following components: Ara-C (4 g/m²/day, injected i.v.) on day-9; Bu (0.8 mg/kg, q6h, injected i.v.) on days -8 to -6; Cy (1.8 g/m²/day, injected i.v.) on days-5 and-4; and ATG (2.5 mg/kg/day) on days-5 to -2.
Treatment groups
Trial outcomes
Primary outcomes
Transplant-related mortality (TRM)
TRM is defined as death due to any transplantation-related cause other than disease relapse. Transplant-related mortality will be calculated using a competing risks model.
Secondary outcomes
Toxicity of conditioning
Toxicity of conditioning within 28 days of HSCT can be graded according to Common Terminology Criteria for Adverse Events (CTCAE): 1.Grade 1: Mild toxicity that does not require medical intervention. 2.Grade 2: Moderate toxicity that may require medical intervention. 3.Grade 3: Severe toxicity that requires significant medical intervention, hospitalization, or results in lasting effects. 4.Grade 4: Life-threatening toxicity, potentially requiring intensive care. 5.Grade 5: Death caused by the toxicity reaction.
Engraftment
Platelet engraftment was defined as the first of seven consecutive days with a platelet count \>20 × 109/L without transfusion support. Neutrophil engraftment was defined as the first of three consecutive days with an ANC \> 0.5 × 109/L.
GVHD
Acute GVHD was classified as symptom presentation before 100 days after haplo-HSCT and chronic GVHD was classified as symptom presentation \>100 days after haplo-HSCT. Each organ (skin, liver, and gut) was staged 1 through 4 for Acute GVHD according to modified criteria based on the schema of the Mount Sinai Acute GVHD International Consortium (MAGIC), and patients were also assigned a grade of acute GVHD (I through IV) based on overall severity. Chronic GVHD was graded in accordance with the National Institutes of Health (NIH) Chronic Graft-versus-Host Disease Consensus Criteria.
Overall Survival
The time from haplo-HSCT to death from any cause in patients with AML. Overall survival will be calculated using the Kaplan-Meier method.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.