Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML

AML Clinical Trial

— IMODLAM  

Official title:

Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02888522
• Other study ID #: 15-182
• Status: Recruiting
• Start date: June 2016
• Est. completion date: January 2020

Study information

• Verified date: August 2016
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2020
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute myeloid leukemia

• Allogeneic stem cell transplantation (related or unrelated)

Exclusion Criteria:

• Age under 18 years

• Cord blood transplantation

Related Conditions & MeSH terms

• AML

Intervention

Biological:
• immunomodulation
Immunomodulation depending on chimerism

Locations

Country	Name	City	State
France	University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of recipient chimerism	whole blood chimerism	3 months
Secondary	Percentage of relapse at 1 year		Relapse rate at 1 year