CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Haploidentical Transplantation
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age14-50
SponsorRuijin Hospital
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing allogeneic hematopoietic stem cell transplantation (any conditioning regimen or graft source is allowed).
Age ≥50 years or ≤14 years
Non-sibling matched transplantation
In vivo or ex vivo T-cell depletion
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
CD45RA-depleted DLI
Biological/VaccineCD45RA Depleted DLI by ex vivo CliniMACS® prepared from mononuclear cell leukapheresis
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Prevention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative Incidence of Overall Viral Infection After CD45RA-Depleted DLI
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.
Time frame
Up to 3 months after the first CD45RA-depleted DLI, assessed at Days 14, 28, 60, and 90.Secondary outcomes
1
Cumulative Incidence of Virus-Specific Infections After CD45RA-Depleted DLI
Report cumulative incidence separately for CMV, EBV, ADV, BKV, HHV6, JCV, and B19 using the protocol-defined PCR thresholds.
Time frame
Up to 3 months after first infusion2
Absolute Counts of Peripheral Blood Lymphocyte Subsets as Measured by Flow Cytometry
Immune reconstitution will be assessed by flow cytometric enumeration of peripheral blood lymphocyte subsets, including CD3+ T cells, CD4+ T cells, CD8+ T cells, CD19+ B cells, CD56+ NK cells, and CD4+CD25+CD127- regulatory T cells.
Time frame
Up to 1 year after the first CD45RA-depleted DLI3
Virus-Specific T-Cell Immune Responses After CD45RA-Depleted DLI
Virus-specific immune reconstitution will be assessed by measuring virus-specific T-cell responses against CMV, EBV, ADV, BKV, B19, HHV6, and JCV using the protocol-defined virus-specific T-cell assay.
Time frame
Up to 3 months after the first CD45RA-depleted DLI, assessed at Days 14, 28, 60, and 90.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ruijin Hospital
Lead sponsor
Shanghai Liquan Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: