Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC
Recruiting now · Phase 1
Conditions studied: Hematologic Malignancy, Haplo-identical Stem Cell Transplantation
In brief
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.
Key facts
- Study ID
- NCT05066412
- Run by
- University Hospital, Geneva
- People needed
- 12
- Starts
- 2024-11-26
- Expected to finish
- 2026-12-02
- Last updated by the study team
- 2025-02-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients who received a stem cell graft from a haploidentical donor after RIC for hematologic malignancies
- Written informed consent of patient and donor obtained
You may not qualify if…
- 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 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
Where it is running
- HUG — Geneva, Canton of Geneva, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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