NCT05066412 Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC
| NCT ID | NCT05066412 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University Hospital, Geneva |
| Condition | Hematologic Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-11-26 |
| Primary Completion | 2026-06-02 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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) * Hematologic or molecular relapse of the primary malignancy requiring chemotherapy or unmanipulated DLI (receiving prophylactic antileukemic agent, eg TKI, is not an exclusion 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