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Intensified Azacitidine in High Risk Myelodysplastic Syndrome (MDS)

NCT01305460 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-12-28

No results posted yet for this study

Summary

A phase I/II study of the efficacy and safety of an intensified schedule of Azacitidine (Vidaza®) in intermediate-2 and high risk MDS patients.

Conditions

Interventions

DRUG

Azacitidine

Treatment will consist of azacitidine 75mg/m2/d for 5 days every 14 days for 4 cycles. * Patients achieving CR or PR will be then treated with 4 cycles of azacitidine 75mg/m2/d for 5 days every 21 days followed by cycles of azacitidine 75mg/m2/d for 7 days administered every 28 days (cycles 9 and beyond), to be continued until progression/relapse or toxicity arises. * Patients not obtaining CR or PR after the initial 4 cycles of azacitidine-14 will continue to receive azacitidine 75mg/m2/d for 5 days every 14 days for 4 additional cycles (cycles 5 to 8). If they achieve CR, PR or HI after 8 cycles, they will then be treated with azacitidine 75mg/m2/d for 5 days every 21 days (cycles 9 to 12) and subsequently cycles of azacitidine 75mg/m2/d for 7 days administered every 28 days (cycles 13 and beyond) until progression/relapse or toxicity arises. * Patients not obtaining CR, PR or HI after 8 cycles of azacitidine-14 will go "off-study".

Sponsors & Collaborators

  • Groupe Francophone des Myelodysplasies

    lead OTHER

Principal Investigators

  • Lionel Adès, MD · Groupe Francophone des Myélodysplasies

  • Simone Boehrer, MD · Groupe Francophone des Myélodysplasies

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-05
Primary Completion
2011-12-31
Completion
2015-11-16

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01305460 on ClinicalTrials.gov