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

NCT ID: NCT02842320

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-14
• Study Completion Date: 2020-07-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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 ...)

Group Type: EXPERIMENTAL

biological samples

Intervention Type: OTHER

bone marrow and blood

Interventions

biological samples

bone marrow and blood

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Nord Franche-Comté

Belfort, , France

Centre Hospitalier Régional Universitaire de Besançon

Besançon, , France

CHU de Dijon

Dijon, , France

CHI de Haute-Saône

Vesoul, , France

Countries

France

Other Identifiers

P/2015/244

Identifier Type: -

Identifier Source: org_study_id