Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC

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 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 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

Conditions3

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