Actively Recruiting
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-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
276
Participants Needed
1
Research Sites
232 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 haploidentical allogeneic hematopoietic stem cell transplantation (haplo-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 haplo-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 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 a written informed consent form.
- Participants must be male or female aged 1 to 17 years.
- Diagnosis of acute lymphoblastic leukemia (ALL) based on WHO criteria for pediatrics aged 1 to 17 years.
- Leukemia must be in hematologic remission (complete remission) before transplantation.
- A suitable haploidentical donor must be available and consent given for haploidentical hematopoietic stem cell transplantation.
- Karnofsky Performance Status score of 70 or higher.
- No significant organ dysfunction: NYHA cardiac class II or below; ALT and AST no more than 2.5 times upper limit of normal; bilirubin no more than 2 times upper limit of normal; serum creatinine no more than 1.5 times upper limit of normal or creatinine clearance rate at least 60 ml/min.
- No significant dyspnea, no need for oxygen therapy, no interstitial lung disease, no active pulmonary infections.
You will not qualify if you...
- Not in hematologic remission before transplantation.
- Using a non-haploidentical related donor.
- Severe cardiac, liver, kidney, or lung disease that prevents tolerating conditioning.
- Active or refractory infection or other life-threatening complications.
- History of other malignant tumors, psychiatric disorders, or HIV infection.
- Refusal to sign informed consent, unwillingness to comply with clinical follow-up, or no consent for use of data in future research.
- Investigator considers the participant unsuitable for any other reason.
AI-Screening
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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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