Actively Recruiting
A Prospective, Randomized Study of TBI or TMLI Conditioning Regimens for Pediatric Acute Lymphoblastic Leukemia Undergoing Haploidentical Stem Cell Transplantation
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2025-02-18
276
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two conditioning regimens for children aged 1 to 17 years with acute lymphoblastic leukemia (ALL) who are undergoing haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT). The study evaluates Total Body Irradiation (TBI) versus Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported by medical literature, but it is unclear which is better. The goal is to find the best regimen to reduce leukemia relapse and improve survival while minimizing side effects. Participants receive either the TMLI regimen or the TBI regimen, each combined with cyclophosphamide. Both radiation treatments deliver a total dose of 12 Gy over three days before transplantation, with 2 Gy given twice daily for six fractions. Cyclophosphamide is administered at 120 mg/kg over two days following radiation. The study is open-label, randomized, and multicenter, aiming to provide evidence on which conditioning method is optimal for pediatric ALL patients undergoing haplo-HSCT. During the study, participants are monitored for relapse-free survival, overall survival, and acute graft-versus-host disease over two years and 100 days respectively. Researchers also assess transplant-related mortality, relapse rates, and conditioning-related side effects. The follow-up includes clinical evaluations and safety monitoring to understand treatment impact and patient outcomes. The total participation duration includes the conditioning period, transplantation, and extended follow-up for at least two years.
CONDITIONS
Brief Title
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-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 sign informed consent.
- Age between 1 and 17 years, any gender.
- Diagnosed with pediatric acute lymphoblastic leukemia (ALL) according to WHO criteria.
- Leukemia must be in complete remission before transplantation.
- Suitable haploidentical donor available and consent for haplo-HSCT.
- Karnofsky score of 70 or higher, able to care for self and perform normal activities.
- No significant organ dysfunction: heart NYHA class II or lower; liver enzymes and bilirubin within allowed limits; kidney function with serum creatinine ≤1.5 times normal or clearance ≥60 ml/min; no serious lung disease or infections.
You will not qualify if you...
- Not in hematologic remission before transplantation.
- Using a non-haploidentical related donor.
- Severe heart, liver, kidney, or lung diseases preventing tolerance of conditioning.
- Active or refractory infections or life-threatening complications.
- History of other cancers, psychiatric disorders, or HIV infection.
- Refusal to sign consent, unwillingness to comply with follow-up, or refusal of data use for research.
- Investigator judges participant unsuitable for other reasons.
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 of Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI) or Total Body Irradiation (TBI) combined with Cyclophosphamide to prepare for stem cell transplantation.
Daily visits for 7 days
Duration - 1 day
Participants undergo haploidentical stem cell transplantation following the conditioning regimen.
1 visit (in-person)
Duration - Up to 2 years
Participants are monitored for transplantation-related outcomes including acute Graft Versus Host Disease and survival for up to 2 years after transplantation.
Regular visits over 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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