Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML)

NCT02842320 | Completed

• 1 other identifier: P/2015/244
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• IL1RAP protein expression on the surface of cells detected by flow cytometry

  up to 2 years after inclusion

Study Arms (1)

Additional biological samples

EXPERIMENTAL

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 ...)

Other: biological samples

Interventions

biological samples OTHER

bone marrow and blood

Additional biological samples

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients for whom there is a strong suspicion of CML diagnosed as part of routine activity.
• written informed consent

You may not qualify if:

• patient with atypical CML
• patient with a non SMP CML
• patients previously treated with interferon
• pregnant or breast-feeding women
• patient under guardianship, curator or under the protection of justice.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (4)

Hôpital Nord Franche-Comté

Belfort, France

Location

Centre Hospitalier Régional Universitaire de Besançon

Besançon, France

Location

CHU de Dijon

Dijon, France

Location

CHI de Haute-Saône

Vesoul, France

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 22, 2016
• Study Start: October 14, 2015
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)