NCT02888522

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 22, 2019

Status Verified

August 1, 2016

Enrollment Period

2 months

First QC Date

August 26, 2016

Last Update Submit

April 18, 2019

Conditions

AML

Outcome Measures

Primary Outcomes (1)

  • Percentage of recipient chimerism

    whole blood chimerism

    3 months

Secondary Outcomes (1)

  • Percentage of relapse at 1 year

    Relapse rate at 1 year

Interventions

immunomodulationBIOLOGICAL

Immunomodulation depending on chimerism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute myeloid leukemia

You may qualify if:

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

You may not qualify if:

  • Age under 18 years
  • Cord blood transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Caen, 14000, France

RECRUITING

MeSH Terms

Interventions

Immunomodulation

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsImmune System Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

September 5, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2016

Study Completion

January 1, 2020

Last Updated

April 22, 2019

Record last verified: 2016-08

Locations

FR(1)