Prophylactic donor lymphocyte infusion for AML patients after stem cell transplantation
Comparative Phase II Trial of Early Prophylactic Donor Lymphocyte Infusion After Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Acute Myeloid Leukemia
This study is testing whether giving extra immune cells from a donor can help prevent acute myeloid leukemia from coming back in patients who have just had a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institut Paoli-Calmettes Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Marseille, Bouches Du Rhône and 1 other locations) |
| Trial ID | NCT03597321 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of prophylactic donor lymphocyte infusion (DLI) in patients with acute myeloid leukemia (AML) who are in hematological complete remission following allogeneic hematopoietic stem cell transplantation (Allo-HSCT). The aim is to minimize the risk of disease recurrence after transplantation by administering DLI as a preventive measure. The study includes patients aged 18 to 70 who meet specific eligibility criteria, including the absence of significant acute graft-versus-host disease (GVHD). The trial is conducted at the Institut Paoli-Calmettes in Marseille, France.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with AML in complete remission who have undergone Allo-HSCT.
Not a fit: Patients with active acute GVHD or those not in complete remission may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of AML in patients after stem cell transplantation.
How similar studies have performed: Previous studies have shown promising results with donor lymphocyte infusion in similar contexts, suggesting potential efficacy in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * AML in hematological complete remission at the time of inclusion * Patient age from 18 to 70. * Able to comply with the protocol. * Written informed consent. * Allogeneic stem cell transplantation from any donor except cord blood. * Unmanipulated bone marrow or peripheral blood stem cells as graft source are allowed * Ongoing GVHD prophylaxis using cyclosporin A at the time of inclusion. Exclusion Criteria: * Presence or history of grade 2 to 4 acute GVHD. * No hematological CR of AML at the time of inclusion. CR patients positive with molecular or phenotypic minimal residual disease (MRD) can be included. * Pregnancy/breast feeding. * Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up. * Concomitant uncontrolled disease and/or organ dysfunction (infection, severe heart, renal, respiratory or hepatic failure...). * Primary or secondary graft failure. * Previous solid organ allogeneic transplantation.
Where this trial is running
Marseille, Bouches Du Rhône and 1 other locations
- Institut Paoli-Calmettes — Marseille, Bouches Du Rhône, France (Not_yet_recruiting)
- Institut Paoli-Calmettes — Marseille, France (Recruiting)
Study contacts
- Principal investigator: Raynier Devillier, MD,PhD — Institut Paoli-Calmettes
- Study coordinator: Jihane PAKRADOUNI, MD
- Email: drci.up@ipc.unicancer.fr
- Phone: +33491223778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.