CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 216 enrolled
Drug / intervention
Oral Azacitidine +2 moredrug
Likely dose
Oral Azacitidine 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01566695
NCT01566695Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes.

Celgene·interventional·Posted Mar 29, 2012·Updated Jan 7, 2025

In Brief

A Phase 3 clinical trial evaluating Oral Azacitidine, Placebo, and 1 other intervention for Myelodysplastic Syndrome. Completed, enrolled 216 participants across 196 sites in 23 countries.

Detailed Summary

Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome
CountriesAustralia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Mexico, Netherlands, Norway, Poland, Portugal, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2012
Enrollment StartApr 26, 2013
Primary CompletionJan 25, 2019
Study CompletionDec 21, 2023
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 14.3 years ago

Interventions

Oral Azacitidinedrug

300 mg daily, days 1 to 21 of each 28-day treatment cycle

Placebodrug

Identically matching placebo tablets on day 1 to 21 of each 28-day treatment cycle.

Best Supportiv Care (BSC)other

BSC included and was not limited to packed RBC (packed red blood cell \[pRBC\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.