NCT03597321Active, not recruitingPhase 2
Early Prophylactic Donor Lymphocyte Infusion After Allo-HSCT for Patients With AML
Comparative Phase II Trial of Early Prophylactic Donor Lymphocyte Infusion After Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is a curative option for patients with acute myeloid leukemia (AML). However, transplantation related toxicity and mortality as well as the existence of HLA identical sibling donor represent major limitations. Over the 20 past years, the development of reduced intensity conditioning (RIC) regimen and the use of alternative donors allowed extending the possibility of Allo-HSCT for AML, with decreased toxicity and mortality. This invited to propose this strategy to more advanced patients, making that AML recurrence has become one of the main issues after Allo-HSCT. Thus, to develop prophylactic and preemptive strategies to minimize disease recurrence after Allo-HSCT is now the main challenge in the field. Among cellular and/or pharmacological treatments after Allo-HSCT, donor lymphocyte infusion (DLI) is probably one of the most commonly used treatments after Allo-HSCT. Indeed, DLI were reported as a potential efficient immunotherapy more than 20 years ago for the treatment of patients with leukemia relapsing after Allo-HSCT. However, most of experiences were reported in the setting of relapse after Allo-HSCT and no prospective evaluation of prophylactic DLI is available so far. Thus no strong recommendation for the use of DLI after Allo-HSCT can be made. Our study proposal would like to assess the question of prophylactic DLI efficacy, as a proof of concept of early immune intervention after Allo-HSCT. The investigators, therefore, designed a prospective multicenter randomized trial evaluating the impact of early DLI on outcome after Allo-HSCT for AML.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 16 Jul 2018
- Start date
- 7 Sept 2020
- Primary completion date
- May 2027
- Lead sponsor
- Institut Paoli-Calmettes
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT03597321
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 124
- From 7 Sept 2020 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant uncontrolled disease and/or organ dysfunction (infection, severe heart, renal, respiratory or hepatic failure…).
- Previous solid organ allogeneic transplantation.
Other illness
- 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.
- Primary or secondary graft failure.
Other
- Pregnancy/breast feeding.
- Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.