Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC
NCT ID: NCT05066412
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2024-11-26
2026-12-02
Brief Summary
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Detailed Description
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Donor lymphocytes are isolated from the original donor by non-mobilized mononuclear cell leukapheresis. Repetitive intravenous infusions (up to 3) of escalating doses of CD45RAneg cells, prepared from the leukapheresis by CliniMACS® technology (CD45RA-depletion), storage in vapor nitrogen.
Escalating doses of CD45RAneg cells, for patients with haploidentical graft, intervals of 6-8 weeks, if GvHD is absent starting ≥ 4 weeks from the day of transplantation.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Prophylactic CD45RA-depleted DLI
CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
Interventions
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CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
Eligibility Criteria
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Inclusion Criteria
* Written informed consent of patient and donor obtained
Exclusion Criteria
* Participant taking Prednisone (or equivalent steroid)
* Participant taking Mycophenolate Mofetil
* Participant taking Cyclosporine/tacrolimus at therapeutic blood levels
* Progressive hematologic malignancy before transplant
* Second allogeneic transplant
* Acute GvHD ≥ grade 2
* Chronic moderate or severe GvHD (NIH consensus criteria)
* Donor aberrant CD45RA expression due to a polymorphism in CD45 gene
* Participation in another interventional clinical trial within 30 days prior to inclusion
* Pregnant or nursing women. Sexually active women with childbearing potential as well as sexually active male patients who are unwilling to use an effective method of contraception during participation in the study from time of inclusion until 2 months after last dose of CD45RAneg DLI infusion
* Inability to follow the procedures of the study, including, but not limited to, language problems, psychological disorders, dementia
18 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Anne-Claire Mamez
Principal Investigator
Locations
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HUG
Geneva, Canton of Geneva, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Cd45RA depleted DLI
Identifier Type: -
Identifier Source: org_study_id
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