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

RECRUITINGPHASE2

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

NCT06559345•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 pediatric ALL patients, with the goal of improving patient quality of life and survival outcomes.

Eligibility

Age

1 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Informed Consent: Participants or guardians must voluntarily sign a written informed consent form.
•2. Age and Gender: Participants should be male or female, aged 1-17 years, inclusive.
•3. Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to pediatrics aged 1-17 years.
•4. Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.
•5. Donor Availability: There must be a suitable haploidentical donor available, and the participant must consent to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT).
•6. Karnofsky Performance Status: The participant must have a Karnofsky score of 70 or higher, indicating that they are capable of caring for themselves and carrying out normal activities. Additionally, they must not have significant organ dysfunction, defined by the following:
•* Cardiac Function: New York Heart Association (NYHA) classification of class II or lower.
•* Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be no more than 2.5 times the upper limit of normal. Bilirubin levels should be no more than 2 times the upper limit of normal.
•* Renal Function: Serum creatinine levels should be no more than 1.5 times the upper limit of normal, or the creatinine clearance rate should be at least 60 ml/min.
•* Pulmonary Function: Participants should not experience significant dyspnea, should not require oxygen therapy, should not have interstitial lung disease, and should not have any active pulmonary infections.

Exclusion Criteria

•To be eligible for inclusion in the study, participants must not meet any of the following criteria:
•1. The patient has not achieved hematologic remission before transplantation.
•2. The patient has chosen a non-haploidentical related donor.
•3. The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.
•4. The patient has an active or refractory infection, or other life-threatening complications.
•5. The patient has a history of other malignant tumors, psychiatric disorders, or HIV infection.
•6. The patients or guardians refuses to sign the informed consent form, is unwilling to comply with clinical follow-up required by the study, or does not consent to the use of their data to support future research, project presentations, and clinical practices.
•7. The investigator deems the patient unsuitable for participation in the study for any other reason.

Locations (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Key Dates

Start Date

March 17, 2025

Primary Completion Date

July 31, 2029

Completion Date

August 31, 2029

Last Updated

February 18, 2025

Enrollment

276

ESTIMATED participants

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Interventions

TMLI

RADIATION

TBI

RADIATION

Cyclophosphamide

DRUG

Contacts

Zhilei Bian, PhD.

CONTACT

+86037166862278 bianzhilei@sina.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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