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

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 ti

Trial Details

NCT ID
NCT06559345
Phase
PHASE2
Sponsor
The First Affiliated Hospital of Zhengzhou University
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • TMLI
  • TBI
  • Cyclophosphamide
Locations (sample)
  • Zhengzhou, Henan, China|34.75778,113.64861

Key Eligibility Criteria

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

For full eligibility, visit ClinicalTrials.gov.

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