Actively Recruiting
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2025-02-18
170
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for MSD-HSCT in pediatric ALL patients, with the goal of improving patient quality of life and survival outcomes.
CONDITIONS
Official Title
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants or guardians must voluntarily sign a written informed consent form.
- Participants should be male or female, aged 1-17 years, inclusive.
- Diagnosis of acute lymphoblastic leukemia (ALL) according to WHO criteria for ages 1-17.
- Leukemia must be in hematologic complete remission before transplantation.
- Availability of a suitable matched sibling donor and consent to undergo MSD-HSCT.
- Karnofsky score of 70 or higher, capable of self-care and normal activities.
- No significant organ dysfunction: cardiac NYHA class II or lower; liver enzymes ALT and AST ≤2.5 times normal; bilirubin ≤2 times normal; renal creatinine ≤1.5 times normal or creatinine clearance ≥60 ml/min.
- No significant pulmonary issues including dyspnea, oxygen therapy, interstitial lung disease, or active lung infections.
You will not qualify if you...
- Has not achieved hematologic remission before transplantation.
- Has chosen a non-matched sibling donor.
- Severe cardiac, liver, kidney, or lung disease preventing tolerance of conditioning.
- Active or refractory infection or other life-threatening complications.
- History of other cancers, psychiatric disorders, or HIV infection.
- Refusal to sign informed consent, unwillingness to comply with follow-up, or no consent for data use.
- Investigator deems patient unsuitable for any other reason.
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450001
Actively Recruiting
Research Team
Z
Zhilei Bian, PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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