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RECRUITING
NCT06564545
PHASE2

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

Sponsor: The First Affiliated Hospital of Zhengzhou University

View on ClinicalTrials.gov

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 adult ALL patients, with the goal of improving patient quality of life and survival outcomes.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2025-03-01

Completion Date

2029-12-31

Last Updated

2025-02-18

Healthy Volunteers

No

Interventions

RADIATION

TBI

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.

RADIATION

TMLI

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.

DRUG

Cyclophosphamide

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