Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML) (CAR-LMC)
Primary Purpose
Chronic Myeloid Leukemia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biological samples
Sponsored by
About this trial
This is an interventional other trial for Chronic Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
- patients for whom there is a strong suspicion of CML diagnosed as part of routine activity.
- written informed consent
Exclusion Criteria:
- patient with atypical CML
- patient with a non SMP CML
- patients previously treated with interferon
- patient enrolled in another study therapy or within the exclusion period thereof
- pregnant or breast-feeding women
- patient under guardianship, curator or under the protection of justice.
Sites / Locations
- Hôpital Nord Franche-Comté
- Centre Hospitalier Régional Universitaire de Besançon
- CHU de Dijon
- CHI de Haute-Saône
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Additional biological samples
Arm Description
Bone marrow sample and blood collected at J0 (screening visit), and at 3, 6, 12, 18 and 24 months and at each additional consultations (relapse ...)
Outcomes
Primary Outcome Measures
IL1RAP protein expression on the surface of cells detected by flow cytometry
Secondary Outcome Measures
Full Information
NCT ID
NCT02842320
First Posted
July 20, 2016
Last Updated
May 31, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02842320
Brief Title
Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML)
Acronym
CAR-LMC
Official Title
Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2015 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The tyrosine kinase inhibitor therapy (iTKs) is the first-line treatment of chronic myelogenous leukemia (CML).
Its effectiveness in controlling the progression of the disease is such that it is possible today to consider stopping treatment in patients with deep molecular response (> RM4.0).
Only in about 50% of cases, patients relapse. It has been shown in these patients that hematopoietic stem cells (HSCs) are persistant, quiescent and insensitive to iTKs. These cells are probably at the origin of relapse. It is therefore necessary to develop complementary therapies to cure the disease and consider discontinuation iTKs The development of anti-tumor immunotherapy approach using genetically modified T cells to express a chimeric antigen receptor (CAR) and specifically targeting CML CSH + could address this issue. The membrane expression of the IL-1-RAP protein could be an interesting target.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Additional biological samples
Arm Type
Experimental
Arm Description
Bone marrow sample and blood collected at J0 (screening visit), and at 3, 6, 12, 18 and 24 months and at each additional consultations (relapse ...)
Intervention Type
Other
Intervention Name(s)
biological samples
Intervention Description
bone marrow and blood
Primary Outcome Measure Information:
Title
IL1RAP protein expression on the surface of cells detected by flow cytometry
Time Frame
up to 2 years after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients for whom there is a strong suspicion of CML diagnosed as part of routine activity.
written informed consent
Exclusion Criteria:
patient with atypical CML
patient with a non SMP CML
patients previously treated with interferon
patient enrolled in another study therapy or within the exclusion period thereof
pregnant or breast-feeding women
patient under guardianship, curator or under the protection of justice.
Facility Information:
Facility Name
Hôpital Nord Franche-Comté
City
Belfort
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Besançon
City
Besançon
Country
France
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
CHI de Haute-Saône
City
Vesoul
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML)
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