Hematopoietic Cell TransplantationPhase 2NCT07867769
Randomised Controlled Trial Comparing CD62L and CD45RA Depleted Donor Lymphocyte Infusion With T-cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
A Phase 2 study testing CD62L depleted DLI, CD45RA depleted DLI and Haploidentical HSCT in people with Hematopoietic Cell Transplantation, run by Hong Kong Children's Hospital at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hematopoietic Cell Transplantation
- What is being tested?
- CD62L depleted DLI, CD45RA depleted DLI and Haploidentical HSCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Oct 2026to 1 Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Children's Hospital
Hong Kong
Daniel KL Cheuk, MBBS, 852-35136049, cheukkld@hku.hk
Wilson YK Chan, MBBS, 852-57413367, cyk956@ha.org.hk
About this study
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.
Read the detailed description
Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the standard therapy for many malignant and non-malignant diseases in children. For patients lacking human leukocyte antigen (HLA)-matched donor, HLA-haploidentical family donor is an increasingly used alternative. In vitro T cell depletion can minimize graft-versus-host disease (GVHD) but increase the risk of infections, graft rejection and relapse of malignancy. CD45RA depleted donor lymphocyte infusion (DLI) can reduce these risks while reducing the risk of GVHD by removing naïve T cells but retaining memory T cells, and is currently one of the standard therapeutic options. The newly developed CD62L depletion may be an even better option that further reduces the risk of infection and GVHD as terminally differentiated CD45RA positive T cells (TEMRA) is retained while central memory T cells are depleted. In this randomized controlled trial, we aim to compare CD62L depleted DLI with CD45RA depleted DLI, in the context of T cell depleted haploidentical HSCT to treat children with malignant or non-malignant disease in need of HSCT. We shall evaluate the frequency of composite viral infections within 100 days of HSCT, overall and disease-free survivals, frequency of acute GVHD, and cumulative incidence of chronic GVHD, malignancy relapse, graft failure and other adverse effects.
- Conditions
- Hematopoietic Cell Transplantation
- Being tested
- CD62L depleted DLI, CD45RA depleted DLI, Haploidentical HSCT
- Keywords
- hematopoietic stem cell transplantation, CD62L depletion, CD45RA depletion, haploidentical transplant, randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD62L depleted DLIBiological
CD62L depleted DLI
CD45RA depleted DLIBiological
CD45RA depleted DLI
Haploidentical HSCTProcedure or surgery
T cell depleted haploidentical HSCT
| Study group | Role | What they receive |
|---|---|---|
| CD62L depleted DLI | Experimental | CD62L depleted DLI Receives: Biological: CD62L depleted DLI; Procedure: Haploidentical HSCT |
| CD45RA depleted DLI | Active comparator | CD45RA depleted DLI Receives: Biological: CD45RA depleted DLI; Procedure: Haploidentical HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of viral infections
Frequency of composite CMV, EBV and/or ADV infections within 100 days of HSCT
Measured: within 100 days after HSCT
Secondary outcomes (7)
Overall survival
Overall survival
Measured: 1 year
disease-free survival
survival without underlying disease recurrence or progression
Measured: 1 year
Frequency of acute GVHD
Frequency of acute GVHD
Measured: 100 days
Cumulative incidence of chronic GVHD
Cumulative incidence of chronic GVHD
Measured: 1 year
Cumulative incidence of relapse of malignancy
Cumulative incidence of relapse of malignancy
Measured: 1 year
Cumulative incidence of graft failure
Cumulative incidence of graft failure
Measured: 1 year
Cumulative incidence of other adverse effects
Cumulative incidence of other adverse effects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start2 Oct 2026
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheuk Ka Leung Daniel, Hong Kong Children's Hospital
- Investigators
- Daniel KL Cheuk, MBBS, Principal investigator, Hong Kong Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867769
- Sponsor's protocol ID
- PAED-2025-117
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized outcome data
Publications
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.
PubMed 40394825Cheuk 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.
PubMed 39892768Verfuerth 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.
PubMed 26076125Zhang 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.
PubMed 22596261Chen 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.
PubMed 14551132Mangare 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.
PubMed 30897843Triplett 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.
PubMed 29178554Triplett 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.
PubMed 25665048Shook 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.
PubMed 25559618Bleakley M. Naive T-cell depletion in stem cell transplantation. Blood Adv. 2020 Oct 13;4(19):4980. doi: 10.1182/bloodadvances.2020001888.
PubMed 33049057
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing CD62L and CD45RA Depleted Donor Lymphocyte Infusion With T-cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07867769
- Acronym / sponsor ID
- PAED-2025-117
- Conditions
- Hematopoietic Cell Transplantation
- Keywords
- hematopoietic stem cell transplantation, CD62L depletion, CD45RA depletion, haploidentical transplant, randomised controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hong Kong Children's HospitalUniversity, hospital or other
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the standard therapy for many malignant and non-malignant diseases in children. For patients lacking human leukocyte antigen (HLA)-matched donor, HLA-haploidentical family donor is an increasingly used alternative. In vitro T cell depletion can minimize graft-versus-host disease (GVHD) but increase the risk of infections, graft rejection and relapse of malignancy. CD45RA depleted donor lymphocyte infusion (DLI) can reduce these risks while reducing the risk of GVHD by removing naïve T cells but retaining memory T cells, and is currently one of the standard therapeutic options. The newly developed CD62L depletion may be an even better option that further reduces the risk of infection and GVHD as terminally differentiated CD45RA positive T cells (TEMRA) is retained while central memory T cells are depleted. In this randomized controlled trial, we aim to compare CD62L depleted DLI with CD45RA depleted DLI, in the context of T cell depleted haploidentical HSCT to treat children with malignant or non-malignant disease in need of HSCT. We shall evaluate the frequency of composite viral infections within 100 days of HSCT, overall and disease-free survivals, frequency of acute GVHD, and cumulative incidence of chronic GVHD, malignancy relapse, graft failure and other adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| CD62L depleted DLI | Experimental | Biological: CD62L depleted DLI, Procedure: Haploidentical HSCTCD62L depleted DLI |
| CD45RA depleted DLI | Active comparator | Biological: CD45RA depleted DLI, Procedure: Haploidentical HSCTCD45RA depleted DLI |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD62L depleted DLICD62L depleted DLI | Biological | CD62L depleted DLI |
| CD45RA depleted DLICD45RA depleted DLI | Biological | CD45RA depleted DLI |
| Haploidentical HSCTT cell depleted haploidentical HSCT | Procedure or surgery | CD45RA depleted DLI, CD62L depleted DLI |
Primary outcome
Frequency of viral infections
Time frame: within 100 days after HSCT
Frequency of composite CMV, EBV and/or ADV infections within 100 days of HSCT
7 secondary outcomes
Overall survival
Time frame: 1 year
disease-free survival
Time frame: 1 year
Frequency of acute GVHD
Time frame: 100 days
Cumulative incidence of chronic GVHD
Time frame: 1 year
Cumulative incidence of relapse of malignancy
Time frame: 1 year
Cumulative incidence of graft failure
Time frame: 1 year
Cumulative incidence of other adverse effects
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 40394825Chan 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.
- Background: PubMed 39892768Cheuk 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.
- Background: PubMed 26076125Verfuerth 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.
- Background: PubMed 22596261Zhang 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.
- Background: PubMed 14551132Chen 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.
- Background: PubMed 30897843Mangare 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.
- Background: PubMed 29178554Triplett 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.
- Background: PubMed 25665048Triplett 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.
- Background: PubMed 25559618Shook 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.
- Background: PubMed 33049057Bleakley M. Naive T-cell depletion in stem cell transplantation. Blood Adv. 2020 Oct 13;4(19):4980. doi: 10.1182/bloodadvances.2020001888.
- Individual participant dataSharing planned: Yes. Anonymized outcome data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel KL Cheuk, MBBS principal investigator
Hong Kong Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD62L depleted DLI, CD45RA depleted DLI and Haploidentical HSCT in people with Hematopoietic Cell Transplantation, run by Hong Kong Children's Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel KL Cheuk, MBBS (852-35136049, cheukkld@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of viral infections (time frame: within 100 days after HSCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07867769, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.