Clinical trial · Interventional
CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Haploidentical Transplantation
CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Transplantation: a Prospective, Multicenter, Single-arm, Pragmatic Clinical Study
NCT07672964CI-TRIAL-00116231CD45RADLIPxnot yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn whether giving patients a special type of donor immune cells (called CD45RA Depleted DLI) can help prevent viral infections after a stem cell transplant. It will also learn about the safety of this treatment. The main questions it aims to answer are: Does this treatment lower the chance of getting serious viral infections after transplant? What medical problems do patients have when receiving this treatment?
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Haplo-identical HCT | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD45RA-depleted DLI | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prevention Group
- description
- Prophylactic CD45RA-depleted DLI
- interventionNames
- Biological: CD45RA-depleted DLI
Primary outcomes (1)
- measure
- Cumulative Incidence of Overall Viral Infection After CD45RA-Depleted DLI
- timeFrame
- Up to 3 months after the first CD45RA-depleted DLI, assessed at Days 14, 28, 60, and 90.
- description
- Overall viral infection is defined as the first occurrence of any qualifying viral infection or reactivation detected by quantitative PCR after the first CD45RA-DLI infusion. Viruses assessed include CMV, EBV, ADV, BKV, HHV6, JCV, and B19. A participant will be considered to have a qualifying viral event if any of the following thresholds are met: CMV DNA ≥250 IU/mL, EBV DNA ≥250 IU/mL, ADV DNA ≥1,000 copies/mL, BKV DNA ≥5,000 copies/mL, HHV6 DNA ≥1,000 copies/mL, JCV DNA ≥1,000 copies/mL, or B19 DNA ≥1,000 copies/mL. The outcome will be reported as the cumulative incidence, expressed as the percentage of participants with at least one qualifying viral infection or reactivation event during the assessment period.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: Participants must meet all of the following criteria: * Patients undergoing allogeneic hematopoietic stem cell transplantation (any conditioning regimen or graft source is allowed). * Presence of at least one high-risk factor for post-transplant viral infection (any of the following): * Age ≥50 years or ≤14 years * Non-sibling matched transplantation * In vivo or ex vivo T-cell depletion * Myeloablative conditioning * Conditioning containing radiotherapy * Second transplantation * CMV IgG or EBV IgG donor/recipient mismatch (donor positive, recipient negative) * History of grade II or higher acute graft-versus-host disease (aGVHD) after transplantation and use of high-dose corticosteroids (prednisone equivalent ≥1 mg/kg/day) * Availability of a suitable lymphocyte donor (see "Donor Selection Criteria"). * Adequate organ function meeting the following laboratory criteria: * Liver function: ALT and AST ≤10× upper limit of normal (ULN); total bilirubin ≤5× ULN * Renal function: BUN and creatinine ≤1.25× ULN * No cardiac dysfunction on electrocardiogram or echocardiogram * Pulmonary function: oxygen saturation \>90% without supplemental oxygen * The patient or legal guardian has the desire and request to receive treatment, signs the informed consent form before treatment, and is willing to comply with the treatment plan, follow-up schedule, and laboratory tests. Exclusion Criteria: Patients meeting any of the following criteria will be excluded from this study: * Active grade II-IV acute graft-versus-host disease (aGVHD) * Active aGVHD requiring prednisone or equivalent corticosteroid \>0.5 mg/kg/day * Active viral infection * Uncontrolled or relapsed malignancy * Other serious acute or chronic physical or psychiatric conditions, or laboratory abnormalities, that may compromise patient safety or compliance, or affect informed consent, study participation, follow-up, or interpretation of results.
References
Publications (0)
Data not yet available
No reference posted for this study.