Conditioning Regimen in Elderly AML Patients Receiving Haplo-HSCT.
Bu/Cy/Flu/ATG Versus Bu/Cy/ATG Conditioning Regimen in Elderly AML Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation: a Prospective, Randomized, Controlled Study
2 other identifiers
interventional
307
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2025
CompletedFirst Posted
Study publicly available on registry
April 27, 2025
CompletedStudy Start
First participant enrolled
May 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
May 11, 2025
May 1, 2025
2.4 years
April 19, 2025
May 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From HSCT to the follow-up assessment at 12 months post-treatment.
Secondary Outcomes (8)
Toxicity of conditioning
From HSCT to the follow-up assessment at 28 days and 100 days post-treatment.
Engraftment
Platelet engraftment was assessment at 28 days post-transplantation.
GVHD
From HSCT to the follow-up assessment at 12 months post-treatment.
Overall Survival
From HSCT to the follow-up assessment at 12 months post-treatment.
Cumulative Incidence of Relapse
From HSCT to the follow-up assessment at 12 months post-treatment.
- +3 more secondary outcomes
Study Arms (2)
Bu/Flu/Cy/ATG
EXPERIMENTALBu/Cy/ATG
ACTIVE COMPARATORInterventions
The 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.
The 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.
Eligibility Criteria
You may qualify if:
- \- (a)Diagnosed with AML in first complete remission (CR1). (b)Age ≥55 years. (c)Availability of an haploidentical donor, first transplant, no matched sibling or unrelated donor.
- (d)Willingness to provide written informed consent.
You may not qualify if:
- (a) Uncontrolled active infection. (b) Secondary AML. (c)Refusal to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, China
Related Publications (4)
Santoro N, Labopin M, Ciceri F, Van Lint MT, Nasso D, Blaise D, Arcese W, Tischer J, Bruno B, Ehninger G, Koc Y, Santarone S, Huang XJ, Savani BN, Mohty M, Ruggeri A, Nagler A. Impact of conditioning intensity on outcomes of haploidentical stem cell transplantation for patients with acute myeloid leukemia 45 years of age and over. Cancer. 2019 May 1;125(9):1499-1506. doi: 10.1002/cncr.31941. Epub 2019 Jan 8.
PMID: 30620383BACKGROUNDSun YQ, Xu LP, Zhang XH, Liu DH, Chen H, Wang Y, Yan CH, Wang JZ, Wang FR, Zhang YY, Liu KY, Huang XJ. A retrospective comparison of BU-fludarabine and BU-CY regimens in elderly patients or in patients with comorbidities who received unmanipulated haploidentical hematopoietic SCT. Bone Marrow Transplant. 2015 Apr;50(4):601-3. doi: 10.1038/bmt.2014.303. Epub 2015 Jan 19. No abstract available.
PMID: 25599162BACKGROUNDHuang XJ, Zhu HH, Chang YJ, Xu LP, Liu DH, Zhang XH, Jiang B, Jiang Q, Jiang H, Chen YH, Chen H, Han W, Liu KY, Wang Y. The superiority of haploidentical related stem cell transplantation over chemotherapy alone as postremission treatment for patients with intermediate- or high-risk acute myeloid leukemia in first complete remission. Blood. 2012 Jun 7;119(23):5584-90. doi: 10.1182/blood-2011-11-389809. Epub 2012 Apr 24.
PMID: 22535659BACKGROUNDSun YQ, Han TT, Wang Y, Yan CH, Wang FR, Wang ZD, Kong J, Chen YH, Chen H, Han W, Chen Y, Zhang YY, Zhang XH, Xu LP, Liu KY, Huang XJ. Haploidentical Stem Cell Transplantation With a Novel Conditioning Regimen in Older Patients: A Prospective Single-Arm Phase 2 Study. Front Oncol. 2021 Feb 26;11:639502. doi: 10.3389/fonc.2021.639502. eCollection 2021.
PMID: 33718234BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 19, 2025
First Posted
April 27, 2025
Study Start
May 20, 2025
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
May 11, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share