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

Chronic Myeloid Leukemia Clinical Trial

— CAR-LMC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842320
• Other study ID #: P/2015/244
• Status: Completed
• Phase: N/A
• Start date: October 14, 2015
• Est. completion date: July 15, 2020

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Other:
• biological samples
bone marrow and blood

Locations

Country	Name	City	State
France	Hôpital Nord Franche-Comté	Belfort
France	Centre Hospitalier Régional Universitaire de Besançon	Besançon
France	CHU de Dijon	Dijon
France	CHI de Haute-Saône	Vesoul

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL1RAP protein expression on the surface of cells detected by flow cytometry		up to 2 years after inclusion