Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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AML

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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immunomodulation

Immunomodulation depending on chimerism

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age under 18 years
* Cord blood transplantation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital

Caen, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Sylvain P Chantepie, MD

Role: primary

[email protected]

+33231272073

Other Identifiers

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15-182

Identifier Type: -

Identifier Source: org_study_id

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