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OpenTrials
Completed

NCT Number: NCT02842320

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Nord Franche-Comté, Belfort, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological Samples

Other

bone marrow and blood

Primary outcomes

  1. IL1RAP protein expression on the surface of cells detected by flow cytometry

    Time frame: up to 2 years after inclusion

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: CAR-LMC

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 22, 2016
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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