Try the modernized beta website. Learn more about the modernization effort.
Working… Menu
Trial record 1 of 9 for:    il1rap
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02842320
Recruitment Status : Unknown
Verified January 2020 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Active, not recruiting
First Posted : July 22, 2016
Last Update Posted : January 29, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Other: biological samples Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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)
Study Start Date : October 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

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

Primary Outcome Measures :
  1. IL1RAP protein expression on the surface of cells detected by flow cytometry [ Time Frame: up to 2 years after inclusion ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02842320

Layout table for location information
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
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Besancon Identifier: NCT02842320    
Other Study ID Numbers: P/2015/244
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases