RecruitingPhase 2NCT06559345

A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL

A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haploidentical Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Pediatric Acute Lymphoblastic Leukemia


Sponsor

The First Affiliated Hospital of Zhengzhou University

Enrollment

276 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of full-body radiation preparation methods (total body irradiation vs. a more targeted approach called TMLI) before a stem cell transplant from a half-matched family donor (haploidentical transplant) for children aged 1–17 with acute lymphoblastic leukemia (ALL) that is in remission. **You may be eligible if...** - You are a child aged 1–17 with a confirmed diagnosis of ALL - Your leukemia is in complete remission before the transplant - You have a suitable half-matched (haploidentical) family donor available - Your heart, liver, kidneys, and lungs are functioning adequately **You may NOT be eligible if...** - Your leukemia is not in complete remission at the time of transplant - You do not have a suitable haploidentical donor - You have serious organ dysfunction that prevents transplant - Your guardians or you (if older) are unable or unwilling to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONTMLI

The total dose of TMLI is 12 Gy, administered on days -7, -6, and -5, with 2 Gy per fraction, twice daily, for a total of 6 fractions.

RADIATIONTBI

The total dose of TBI is 12 Gy, administered on days -7, -6, and -5, with 2 Gy per fraction, twice daily, for a total of 6 fractions.

DRUGCyclophosphamide

The total dose of cyclophosphamide is 120 mg/kg, administered over 2 days on days -4 and -3.


Locations(1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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NCT06559345


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