CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
5-azacytidinedrug
Likely dose
5-azacytidine 75 mg/m2from 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/NCT00721214
NCT00721214Phase 2Completed

A Phase II Study of the Use of 5-Azacytidine as Pre-Transplant Cytoreduction Prior to Allogeneic Stem Cell Transplantation for High Risk Myelodysplastic Syndromes

Virginia Commonwealth University·interventional·Posted Jul 24, 2008·Updated Mar 2, 2016

In Brief

A Phase 2 clinical trial evaluating 5-azacytidine for Myelodysplastic Syndrome. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the feasibility and efficacy of using the demethylating agent 5-Azacytidine prior to allogeneic stem cell transplantation in patients with high risk myelodysplastic syndrome (MDS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCelgene Corporation

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 24, 2008
Enrollment StartJul 1, 2008
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 17.9 years ago

Interventions

5-azacytidinedrug

The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days.