RecruitingPhase 2NCT06564493

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

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


Sponsor

The First Affiliated Hospital of Zhengzhou University

Enrollment

170 participants

Start Date

Mar 1, 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 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.


Eligibility

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of stem cell transplant conditioning regimens in children aged 1–17 with acute lymphoblastic leukemia (ALL — a type of blood cancer) who are in complete remission and have a matched sibling donor available, to see which approach leads to better outcomes with fewer complications. **You may be eligible if...** - You are age 1–17 and have been diagnosed with ALL (a type of leukemia) - Your leukemia is in complete remission (cancer not detectable in blood) - You have a fully matched sibling who can donate stem cells - You are in reasonably good health (Karnofsky score ≥70) - Your heart, liver, kidney, and lung function are within acceptable ranges **You may NOT be eligible if...** - Your leukemia is not in remission - You do not have a matched sibling donor - You have significant organ problems affecting the heart, liver, or kidneys - You have active, uncontrolled infection - You have previously had a stem cell transplant 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

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.

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.

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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NCT06564493


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