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

C

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Chronic Myeloid Leukemia

Treatments

Other: biological samples

Study type

Interventional

Funder types

Other

Identifiers

NCT02842320
P/2015/244

Details and patient eligibility

About

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.

Enrollment

53 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

53 participants in 1 patient group

Additional biological samples
Experimental group
Description:
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 ...)
Treatment:
Other: biological samples

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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