NCT07867769

Brief Summary

The goal of clinical trial is to compare the efficacy and safety of CD62L depleted donor lymphocyte infusion (DLI) with CD45RA depleted DLI in children who receive T-cell depleted haploidentical hematopoietic stem cell transplantation (HSCT). Participants will be randomised to receive either CD62L depleted DLI or CD45RA depleted DLI with HSCT and evaluate for efficacy and safety outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
37mo left

Started Oct 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Oct 2029

Study Start

First participant enrolled

October 2, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

3 years

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Hematopoietic Cell Transplantation

Keywords

hematopoietic stem cell transplantationCD62L depletionCD45RA depletionhaploidentical transplantrandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Frequency of viral infections

    Frequency of composite CMV, EBV and/or ADV infections within 100 days of HSCT

    within 100 days after HSCT

Secondary Outcomes (7)

  • Overall survival

    1 year

  • disease-free survival

    1 year

  • Frequency of acute GVHD

    100 days

  • Cumulative incidence of chronic GVHD

    1 year

  • Cumulative incidence of relapse of malignancy

    1 year

  • +2 more secondary outcomes

Study Arms (2)

CD62L depleted DLI

EXPERIMENTAL

CD62L depleted DLI

Biological: CD62L depleted DLIProcedure: Haploidentical HSCT

CD45RA depleted DLI

ACTIVE COMPARATOR

CD45RA depleted DLI

Biological: CD45RA depleted DLIProcedure: Haploidentical HSCT

Interventions

CD62L depleted DLIBIOLOGICAL

CD62L depleted DLI

CD62L depleted DLI
CD45RA depleted DLIBIOLOGICAL

CD45RA depleted DLI

CD45RA depleted DLI
Haploidentical HSCTPROCEDURE

T cell depleted haploidentical HSCT

CD45RA depleted DLICD62L depleted DLI

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Children's Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (10)

  • Chan WYK, Lee PPW, Cheuk DKL, Chiang AKS, Leung W. A Modified Three-Step Haploidentical Transplantation With TCRalphabeta/CD62L Depletion for Epstein-Barr Virus Hemophagocytic Lymphohistiocytosis and Natural Killer-Cell Lymphoproliferative Disease. Pediatr Blood Cancer. 2025 Aug;72(8):e31818. doi: 10.1002/pbc.31818. Epub 2025 May 20. No abstract available.

    PMID: 40394825BACKGROUND

  • Cheuk DKL, Lee PPW, Chan WYK, Chan GCF, So CC, Leung WH. Novel CD62L depleted donor lymphocyte infusion with T-cell receptor alpha-beta depleted haploidentical hematopoietic stem cell transplantation in children. Transpl Immunol. 2025 Mar;89:102176. doi: 10.1016/j.trim.2025.102176. Epub 2025 Jan 30.

    PMID: 39892768BACKGROUND

  • Verfuerth S, Sousa PS, Beloki L, Murray M, Peters MD, O'Neill AT, Mackinnon S, Lowdell MW, Chakraverty R, Samuel ER. Generation of memory T cells for adoptive transfer using clinical-grade anti-CD62L magnetic beads. Bone Marrow Transplant. 2015 Oct;50(10):1358-64. doi: 10.1038/bmt.2015.135. Epub 2015 Jun 15.

    PMID: 26076125BACKGROUND

  • Zhang J, Barefoot BE, Mo W, Deoliveira D, Son J, Cui X, Ramsburg E, Chen BJ. CD62L- memory T cells enhance T-cell regeneration after allogeneic stem cell transplantation by eliminating host resistance in mice. Blood. 2012 Jun 28;119(26):6344-53. doi: 10.1182/blood-2011-03-342055. Epub 2012 May 17.

    PMID: 22596261BACKGROUND

  • Chen BJ, Cui X, Sempowski GD, Liu C, Chao NJ. Transfer of allogeneic CD62L- memory T cells without graft-versus-host disease. Blood. 2004 Feb 15;103(4):1534-41. doi: 10.1182/blood-2003-08-2987. Epub 2003 Oct 9.

    PMID: 14551132BACKGROUND

  • Mangare C, Tischer-Zimmermann S, Riese SB, Dragon AC, Prinz I, Blasczyk R, Maecker-Kolhoff B, Eiz-Vesper B. Robust Identification of Suitable T-Cell Subsets for Personalized CMV-Specific T-Cell Immunotherapy Using CD45RA and CD62L Microbeads. Int J Mol Sci. 2019 Mar 20;20(6):1415. doi: 10.3390/ijms20061415.

    PMID: 30897843BACKGROUND

  • Triplett BM, Muller B, Kang G, Li Y, Cross SJ, Moen J, Cunningham L, Janssen W, Mamcarz E, Shook DR, Srinivasan A, Choi J, Hayden RT, Leung W. Selective T-cell depletion targeting CD45RA reduces viremia and enhances early T-cell recovery compared with CD3-targeted T-cell depletion. Transpl Infect Dis. 2018 Feb;20(1):10.1111/tid.12823. doi: 10.1111/tid.12823. Epub 2018 Jan 16.

    PMID: 29178554BACKGROUND

  • Triplett BM, Shook DR, Eldridge P, Li Y, Kang G, Dallas M, Hartford C, Srinivasan A, Chan WK, Suwannasaen D, Inaba H, Merchant TE, Pui CH, Leung W. Rapid memory T-cell reconstitution recapitulating CD45RA-depleted haploidentical transplant graft content in patients with hematologic malignancies. Bone Marrow Transplant. 2015 Jul;50(7):968-77. doi: 10.1038/bmt.2014.324. Epub 2015 Feb 9.

    PMID: 25665048BACKGROUND

  • Shook DR, Triplett BM, Eldridge PW, Kang G, Srinivasan A, Leung W. Haploidentical stem cell transplantation augmented by CD45RA negative lymphocytes provides rapid engraftment and excellent tolerability. Pediatr Blood Cancer. 2015 Apr;62(4):666-73. doi: 10.1002/pbc.25352. Epub 2015 Jan 5.

    PMID: 25559618BACKGROUND

  • Bleakley M. Naive T-cell depletion in stem cell transplantation. Blood Adv. 2020 Oct 13;4(19):4980. doi: 10.1182/bloodadvances.2020001888.

    PMID: 33049057BACKGROUND

Study Officials

  • Daniel KL Cheuk, MBBS

    Hong Kong Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel KL Cheuk, MBBS

CONTACT

852-35136049cheukkld@hku.hk

Wilson YK Chan, MBBS

CONTACT

852-57413367cyk956@ha.org.hk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start

October 2, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will share

Anonymized outcome data

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
IPD will be available from the time of publication till 1 Oct 2032 (3 years after end of study)
Access Criteria
Publisher and authorized people will be able to access individual anonymized outcome data by email

Locations

HK(1)