Prophylactic treatment using donor lymphocytes after haploidentical stem cell transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and feasibility of administering prophylactic CD45RA-depleted donor lymphocyte infusions (DLI) in patients who have undergone haploidentical stem cell transplantation following a reduced intensity conditioning regimen. The study involves isolating donor lymphocytes through leukapheresis and administering escalating doses of these cells intravenously in the early post-transplant period, provided that no acute graft-versus-host disease (GvHD) is present. The primary objective is to determine the safety of this approach in preventing complications related to the transplant.

Why it matters

Who can join: the full rules

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

Where it's running

• Hug
  Geneva, Canton of Geneva, Switzerland Recruiting

Study contacts

• Study coordinator: Anne-Claire Mamez
• Email: anne-claire.mamez@hcuge.ch
• Phone: +41786656487

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.