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Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML

Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02888522
Acronym
IMODLAM
Enrollment
60
Registered
2016-09-05
Start date
2016-06-30
Completion date
2020-01-31
Last updated
2019-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML

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.

Interventions

Immunomodulation depending on chimerism

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Acute myeloid leukemia * Allogeneic stem cell transplantation (related or unrelated)

Exclusion criteria

* Age under 18 years * Cord blood transplantation

Design outcomes

Primary

MeasureTime frameDescription
Percentage of recipient chimerism3 monthswhole blood chimerism

Secondary

MeasureTime frame
Percentage of relapse at 1 yearRelapse rate at 1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026