Prophylactic treatment using donor lymphocytes after haploidentical stem cell transplantation

A Phase I Clinical Trial Assessing Prophylactic Donor CD45RA-depleted Lymphocyte Infusions Into Patients Transplanted with Stem Cell Grafts from Haploidentical Donors After Reduced Intensity Conditioning

This study is testing if giving special donor immune cells to patients after a specific type of stem cell transplant can help prevent complications safely.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Geneva (other)
• Drugs / interventions: chemotherapy, Prednisone
• Locations: 1 site (Geneva, Canton of Geneva)
• Trial ID: NCT05066412 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients who have received a haploidentical stem cell graft after reduced intensity conditioning for hematologic malignancies.

Not a fit: Patients with progressive hematologic malignancies, significant GvHD, or those on certain immunosuppressive therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance the safety and effectiveness of haploidentical stem cell transplants for patients with hematologic malignancies.

How similar studies have performed: While the approach of using donor lymphocyte infusions is established, the specific use of CD45RA-depleted cells in this context is novel and has not been extensively tested in prior studies.

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 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 this trial is running

Geneva, Canton of Geneva

• HUG — Geneva, Canton of Geneva, Switzerland (RECRUITING)

Study contacts

• Study coordinator: Anne-Claire Mamez

Conditions: Hematologic Malignancy, Haplo-identical Stem Cell Transplantation