NCT04169022

Brief Summary

AML is one of the most aggressive forms of leukemia, where bone marrow transplantation remains the gold standard treatment, with its known associated toxicities and related mortality. Despite progress in the treatment of leukemic malignancies, especially the emergence of targeted- and immuno-therapies arising from biological genomic knowledge, there remains a need to provide additional strategies for refractory/relapsing (R/R) patients Aim of this study is to collect biological samples of AML patients in order to validate our Chimeric Antigen Receptor T-cells immunotherapy approach

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

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

May 16, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 10, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

4.2 years

First QC Date

May 16, 2019

Last Update Submit

February 8, 2024

Conditions

Acute Myeloid Leukemia

Keywords

AMLChimeric Antigen Receptor T CellsImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • IL1RAP protein expression

    Cytometry analysis

    2 years

Study Arms (2)

AML patients at diagnosis

EXPERIMENTAL

AML patients at diagnosis (except AML3)

Other: Sample collection

AML patients at relapse

EXPERIMENTAL

AML patients at relapse after chemotherapy, targeted therapy or allograft

Other: Sample collection

Interventions

Sample collectionOTHER

Sample collection blood and/or bone marrow

AML patients at diagnosisAML patients at relapse

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • AML patients adults and pediatrics

You may not qualify if:

  • AML3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2019

First Posted

November 19, 2019

Study Start

July 10, 2019

Primary Completion

October 2, 2023

Study Completion

October 2, 2023

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations

FR(1)