NCT03449745

Brief Summary

This project aim at deciphering immune mechanisms that allow the immunoescape of AML initiating cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 29, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

3 years

First QC Date

February 22, 2018

Last Update Submit

April 19, 2022

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid LeukemiaImmune Checkpoint LigandFlow Cytometry

Outcome Measures

Primary Outcomes (1)

  • Immune checkpoints (ICP) ligand expression

    Compare large panel of ICP ligand expression between LIC and HSC by flow cytometry

    At inclusion

Secondary Outcomes (2)

  • Levels of ICP ligand expression

    At inclusion

  • Levels of ICP ligand expression

    At inclusion

Eligibility Criteria

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

Patients with Acute Myeloid Leukemia

You may qualify if:

  • ≥ 18 years of age
  • newly diagnosed AML

You may not qualify if:

  • isolated extramedullary AML
  • mixed phenotype acute leukemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Edouard FORCADE

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 22, 2018

First Posted

February 28, 2018

Study Start

May 29, 2018

Primary Completion

June 9, 2021

Study Completion

June 9, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)