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 : Active, not recruiting
First Posted : July 22, 2016
Last Update Posted : January 29, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- IL1RAP protein expression on the surface of cells detected by flow cytometry [ Time Frame: up to 2 years after inclusion ]
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
|Hôpital Nord Franche-Comté|
|Centre Hospitalier Régional Universitaire de Besançon|
|CHU de Dijon|
|CHI de Haute-Saône|