Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-29

Study Completion Date

2026-12-31

Brief Summary

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In this comparative study, the investigators aim to compare prospective pediatric patients who receive total lymphoid irradiation (TLI) using tomotherapy with age- and disease-matched controls who receive conventional total body irradiation (TBI) as part of conditioning for haploidentical hematopoietic stem cell transplantation (HSCT) for both malignant and non-malignant diseases. The investigators shall evaluate graft failure-free, graft-versus-host disease (GVHD)-free survival, overall survival, frequency of rejection, GVHD, relapse of malignancy, adverse effects and post-transplant immunoreconstitution.

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Detailed Description

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Radiotherapy at a dose of 6Gy divided into 3 equal fractions (2Gy per fraction) to all lymphoid organs (TLI) over 2 days using tomotherapy will be given to participants as part of the conditioning treatment before haploidentical hematopoietic stem cell transplantation (HSCT). Retrospective patients who are age- and disease-matched with the recruited patients and had received radiotherapy to the whole body (TBI) with or without lung shielding at a total dose of 2-12 Gy delivered as 1-6 equal fractions by conventional opposed fields radiotherapy as part of conditioning will be compared for the outcomes.

Conditions

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Hematopoietic Organs; Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Total lymphoid irradiation (TLI)

Group Type EXPERIMENTAL

Total lymphoid irradiation

Intervention Type RADIATION

Total lymphoid irradiation (TLI) 6Gy by tomotherapy as part of conditioning treatment before haploidentical hematopoietic stem cell transplant

Interventions

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Total lymphoid irradiation

Total lymphoid irradiation (TLI) 6Gy by tomotherapy as part of conditioning treatment before haploidentical hematopoietic stem cell transplant

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Aged 0-18 years who requires allogeneic HSCT, has no human leukocyte antigen (HLA)-matched sibling donor but has an HLA-haploidentical donor.
* Adequate organ function to tolerate the conditioning chemotherapy and radiotherapy
* Karnofsky or Lansky performance status score ≥50

Exclusion Criteria

* Pregnant or lactating woman
* HIV infection
* Patients for whom alternative treatment is deemed more appropriate by treating physician
* Patients who are unlikely to benefit from haploidentical hematopoietic stem cell transplantation, e.g., terminal malignancy with multiorgan failure

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No