Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC
A Phase I Clinical Trial Assessing Prophylactic Donor CD45RA-depleted Lymphocyte Infusions Into Patients Transplanted with Stem Cell Grafts from Haploidentical Donors After Reduced Intensity Conditioning
University Hospital, Geneva
12 participants
Nov 26, 2024
INTERVENTIONAL
Conditions
Summary
To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.
Eligibility
Inclusion Criteria2
- Patients who received a stem cell graft from a haploidentical donor after RIC for hematologic malignancies
- Written informed consent of patient and donor obtained
Exclusion Criteria12
- Participant taking Prednisone (or equivalent steroid)
- 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
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Interventions
CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05066412