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

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ClinicalTrials.gov Identifier: NCT02842320
Recruitment Status : Recruiting
First Posted : July 22, 2016
Last Update Posted : October 17, 2017
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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 ClinicalTrials.gov identifier (NCT number): NCT02842320


Contacts
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Contact: Christophe FERRAND, Dr christophe.ferrand@efs.sante.fr
Contact: Fabrice LAROSA, Dr flarosa@chu-besancon.fr

Locations
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France
Hôpital Nord Franche-Comté Recruiting
Belfort, France
Contact: Marius Moldovan, Dr         
Principal Investigator: Marius Moldovan, Dr         
Centre Hospitalier Régional Universitaire de Besançon Recruiting
Besançon, France
Contact: Fabrice LAROSA, Dr       flarosa@chu-besancon.fr   
CHU de Dijon Recruiting
Dijon, France
Contact: Denis CAILLOT, Dr       denis.caillot@chu-dijon.fr   
Principal Investigator: Denis CAILLOT, Dr         
CHI de Haute-Saône Recruiting
Vesoul, France
Contact: Cyril FAURE, Dr         
Principal Investigator: Cyril FAURE, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02842320     History of Changes
Other Study ID Numbers: P/2015/244
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases