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

Not Applicable

Completed

• Conditions: Chronic Myeloid Leukemia
• Interventions: Other: biological samples

• Registration Number: NCT02842320
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-14
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-22
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Additional biological samples	biological samples	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 ...)

Primary Outcome Measures

Name	Time	Method
IL1RAP protein expression on the surface of cells detected by flow cytometry	up to 2 years after inclusion

Trial Locations

Locations (4)

CHU de Dijon; 🇫🇷 Dijon, France

Centre Hospitalier Régional Universitaire de Besançon; 🇫🇷 Besançon, France

Hôpital Nord Franche-Comté; 🇫🇷 Belfort, France

CHI de Haute-Saône; 🇫🇷 Vesoul, France