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Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes

NCT01305135 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2017-06-07

No results posted yet for this study

Summary

Patients will receive escalating doses of ldarubicin combined to Azacitidine given at the FDA/EMEA approved Schedule and dosing.

For the Phase I study :

Determine the safety and tolerance of escalating doses of Idarubicin combined to Azacitidine in patients with INT-2 or higher risk MDS.

For the phase II study:

Primary: Evaluate rate and duration of response (according to IWG 2006 criteria and IWG 2000 criteria) to the combination of Idarubicin and Azacitidine in patients with INT-2 or higher risk MDS

Conditions

  • High Grade Myelodysplastic Syndrome Lesions

Interventions

DRUG

azacitidine and idarubicin

azacitidine:100mg, 75mg/m²/d, during 7days every 28 days (D1-D7). Idarubicin: 5mg/ml, 5mg/m²/d (palier1) or 10mg/m²/d (palier2), D8

Sponsors & Collaborators

  • Groupe Francophone des Myelodysplasies

    lead OTHER

Principal Investigators

  • Lionel ADES, PHD,MD · GFM: Groupe Francophone des Myélodysplasies

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-30
Primary Completion
2011-06-30
Completion
2016-05-09

Countries

  • France
  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01305135 on ClinicalTrials.gov