Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML
- Conditions
- AML
- Registration Number
- NCT02888522
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is now an effective treatment of Acute Myeloid Leukemia (AML). After allo-HSCT, relapses are the major cause of mortality and occur in about 30% of cases. The occurrence of relapses is important during the first three months post-allogeneic transplant, then gradually decreases during the first year post-allograft and then becomes weaker. After relapse, therapeutic options include the reduction of immunosuppression, the administration of donor lymphocytes (DLI), chemotherapy or a new transplant. The performance is influenced by the early introduction of treatment whose effectiveness is related to the importance of tumor burden. Immunomodulation of preemptive strategies have recently been established by decreasing immunosuppression and achieve DLIs in patients with a high risk of relapse, before the occurrence of relapse.
The aim of this study is to evaluate the incidence of relapse following the recommendations of post-allogeneic transplant immunomodulation of the French society of bone marrow transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Acute myeloid leukemia
- Allogeneic stem cell transplantation (related or unrelated)
- Age under 18 years
- Cord blood transplantation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of recipient chimerism 3 months whole blood chimerism
- Secondary Outcome Measures
Name Time Method Percentage of relapse at 1 year Relapse rate at 1 year
Trial Locations
- Locations (1)
University Hospital
🇫🇷Caen, France