Actively Recruiting
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Matched Sibling Donor Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Pediatric Lymphoblastic Leukemia
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2025-02-18
170
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two different conditioning treatments for children with acute lymphoblastic leukemia (ALL) who are undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT). The study evaluates Total Body Irradiation (TBI) against Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI), both combined with cyclophosphamide. The goal is to find which regimen better eliminates leukemia cells in bone marrow and lymphoid tissues while causing less damage to healthy tissues, potentially reducing relapse and transplant-related complications. Participants receive either the TMLI or TBI radiation therapy, each delivering a total dose of 12 Gy over three days with twice daily fractions. Both groups also receive cyclophosphamide at a total dose of 120 mg/kg given over two days. The study is randomized and open-label, conducted across multiple centers, focusing on pediatric patients aged 1 to 17 years. The treatments are given before the stem cell transplant to prepare the body. During the study, participants will be monitored for 2 years after transplantation to assess relapse-free survival, overall survival, and acute graft-versus-host disease within the first 100 days. Additional outcomes include transplant-related mortality, relapse rate, and adverse events related to conditioning. The study tracks patient health through clinical assessments to determine which conditioning approach offers better outcomes and lower toxicity in children with ALL.
CONDITIONS
Brief 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.
- Male or female participants aged 1 to 17 years.
- Diagnosed with acute lymphoblastic leukemia (ALL) according to WHO criteria.
- Leukemia must be in hematologic remission (complete remission) before transplantation.
- Suitable matched sibling donor must be available.
- Participant must consent to undergo matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT).
- Karnofsky Performance Status score of 70 or higher.
- No significant organ dysfunction: cardiac function NYHA class II or lower, liver enzymes ALT and AST no more than 2.5 times normal, bilirubin no more than 2 times normal, renal creatinine no more than 1.5 times normal or creatinine clearance at least 60 ml/min.
- No significant pulmonary issues such as dyspnea, oxygen therapy requirement, interstitial lung disease, or active pulmonary infections.
You will not qualify if you...
- Not in hematologic remission before transplantation.
- Chose a donor other than a matched sibling donor.
- Severe cardiac, liver, kidney, or lung diseases making conditioning intolerable.
- Active or refractory infections or other life-threatening complications.
- History of other cancers, psychiatric disorders, or HIV infection.
- Refusal to sign informed consent or unwillingness to comply with clinical follow-up or data use.
- Investigator deems patient unsuitable for any other reason.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants receive a conditioning regimen with either Total Body Irradiation (TBI) or Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI) plus Cyclophosphamide before transplantation.
Multiple visits over 7 days before transplantation
Duration - 1 day
Participants undergo matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT).
1 visit (in-person) for transplantation
Duration - Up to 2 years
Participants are monitored for transplant-related outcomes including graft versus host disease and survival.
Regular follow-up visits for up to 2 years
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.
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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