CD62L-depleted versus CD45RA-depleted donor lymphocyte infusions after haploidentical HSCT in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 trial compares two donor lymphocyte infusion strategies given after T-cell depleted haploidentical hematopoietic stem cell transplantation in pediatric patients. The study looks at safety and efficacy, including infection rates, graft-versus-host disease, relapse, and survival within the first year after transplant. All participants receive the same HSCT approach with either CD62L-depleted DLI or CD45RA-depleted DLI, allowing direct comparison of outcomes. The trial is conducted at Hong Kong Children's Hospital and targets children aged 0-18 who lack an HLA-matched donor but have a haploidentical family donor. Primary endpoints include viral infections within 100 days post-transplant and rates of acute and chronic GVHD, with secondary endpoints covering disease-free survival, overall survival, relapse, and graft rejection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 0-18 years who requires allogeneic hematopoietic stem cell transplant, has no 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
* Patients who are unlikely to benefit from haploidentical HSCT, e.g., terminal malignancy with multiorgan failure

Where it's running

• Hong Kong Children's Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Daniel KL Cheuk, MBBS — Hong Kong Children's Hospital
• Study coordinator: Daniel KL Cheuk, MBBS
• Email: cheukkld@hku.hk
• Phone: 852-35136049

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.