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

• Sponsor: Centre Hospitalier Universitaire de Besancon (Other)
• Overall Status: Completed
• CT.gov ID: NCT02842320
• Collaborator: (none)
• Enrollment: 53
• Locations: 4
• Arm: 1
• Actual Duration (Months): 57
• Patients Per Site: 13.3
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia	Other: biological samples	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML)
• Actual Study Start Date: Oct 14, 2015
• Actual Primary Completion Date: Jul 15, 2020
• Actual Study Completion Date: Jul 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Additional 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 ...)	Other: biological samples; bone marrow and blood

Outcome Measures

Primary Outcome Measures

1. IL1RAP protein expression on the surface of cells detected by flow cytometry [up to 2 years after inclusion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Nord Franche-Comté	Belfort		France
2	Centre Hospitalier Régional Universitaire de Besançon	Besançon		France
3	CHU de Dijon	Dijon		France
4	CHI de Haute-Saône	Vesoul		France

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Besancon
• ClinicalTrials.gov Identifier: NCT02842320
• Other Study ID Numbers: P/2015/244
• First Posted: Jul 22, 2016
• Last Update Posted: Jun 1, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study Results

No Results Posted as of Jun 1, 2022