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NCT01210274Recruiting

Characterization of the Mechanisms of Resistance to Azacitidine

Characterization of the Mechanisms of Action of Resistance to Azacitidine in High-risk Myelodysplastic Syndromes and Acute Myeloid Leukemia With Multilineage Dysplasia

Source: ClinicalTrials.gov · Last updated 19 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Myelodysplastic syndromes (MDS) are frequent diseases in elderly patients (median age: 71 years). IPSS classification defines low risk (Low and Intermediate 1), and high risk (Intermediate 2 and High) MDS. High-risk MDS (MDS-HR) have a high risk of transformation into acute leukemia with multilineage dysplasia (AML-DML). The success of Azacitidine has been mainly achieved through a rigorous empirical and clinical research, but the molecular mechanisms by which this molecule exerts its effects remain poorly characterized. The primary mode of action of Azacytidine is through DNA demethylation, and integration in to mRNA that favor traduction inhibition. The impact of this molecule on various cell death programs involved in the elimination of leukemic cells : apoptosis and autophagy is currently poorly known. The research program and clinical studies we proposed focus on two major aspects: \- Main objective: Molecular mechanism of action and resistance to Azacitidine: Role of apoptosis versus autophagy. \- Secondary Objective: Reversion of Azacytidine resistance using different drugs targeting apoptosis and/or autophagy. Our laboratory has identified new molecules to selectively induce different types of cell death (apoptosis or autophagy).

Status (registry)
Recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
27 Sept 2010
Start date
1 Sept 2010
Primary completion date
30 Sept 2014
Lead sponsor
Centre Hospitalier Universitaire de Nice
NCT number
NCT01210274

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From 1 Sept 2010 to the primary completion date, 30 Sept 2014
  • 4 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with others chemotherapies alone or in association

Who the study is looking for

  • Age ≥ 18 years
  • High Risk or Intermediate 2 MDS (IPSS)
  • AML-MD (WHO classification)
  • Treatment with minimum three to six cycles of Azacitidine
  • Informed consent form signed

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CH d'Antibes
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AntibesFranceRecruiting
Centre Antoine Lacassagne
Coordinator of this site? Confirm its status
NiceFranceRecruiting
Chu de Nice Hopital de L'Archet
Coordinator of this site? Confirm its status
NiceFranceRecruiting
CH Princesse Grace
Coordinator of this site? Confirm its status
MonacoMonacoRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.