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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-17
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

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 criteria

Qualifiers

Informed Consent: Participants or guardians must voluntarily sign a written informed consent form.

Age and Gender: Participants should be male or female, aged 1-17 years, inclusive.

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.

Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.

Disqualifiers

The patient has not achieved hematologic remission before transplantation.

The patient has chosen a non-haploidentical related donor.

The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.

The patient has an active or refractory infection, or other life-threatening complications.

Trial design

Treatments tested in this trial

  • TMLI
  • TBI
  • Cyclophosphamide

Treatment groups

276 Participants
are divided into 2 treatment groups