Haplo-identical Stem Cell Transplantation, Hematologic Malignancy
Conditions
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.
Detailed description
Primary Objective is to determine whether the administration of prophylactic CD45RAneg (CD45RAneg) memory/effector T lymphocytes is feasible and safe in the early post-transplant period for patients with haploidentical transplant and RIC conditioning. 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.
Interventions
OTHERCD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
Sponsors
University Hospital, Geneva
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute transfusion reaction (CTCAE ≥ 2) | 24 hours after each CD45RA neg DLI infusion | acute transfusion reaction after each DLI infusion (CTCAE ≥ 2) |
| acute GvHD grade II-IV | within 8 weeks after each CD45RAneg DLI infusion | acute GvHD grade II-IV measured with MAGIC score |
Countries
Switzerland
Contacts
Primary ContactAnne-Claire Mamez
Outcome results
None listed