At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 62 enrolled
Drug / intervention
5-Azacytidine +2 moredrug
Likely dose
Not stated in 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.
A Open Label, Phase II, Non Randomized, Clinical Trial of Chemotherapy Treatment With 5-Azacytidine Plus Valproic Acid and Eventually Atra for Patients Diagnosed With Intermediate II and High Risk Myelodysplastic Syndrome (MDS). EudraCT Number 2005-004811-31. GIMEMA Protocol MDS0205
Gruppo Italiano Malattie EMatologiche dell'Adulto·interventional·Posted Feb 26, 2007·Updated Aug 7, 2018
In Brief
A Phase 2 clinical trial evaluating 5-Azacytidine, Valproic Acid, and 1 other intervention for Myelodysplastic Syndromes. Completed, enrolled 62 participants across 7 sites.
Detailed Summary
The primary objective of the trial is to assess the activity of the combined use of Valproic Acid (VPA)in combination with 5-Azacytidine (5-Aza C) in the treatment of MDS. Activity will be evaluated as percentage of patients achieving complete or partial remission.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes
CountriesItaly
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2007
Enrollment StartMay 2007
Primary CompletionJul 2010
TodayJul 2026
First PostedFeb 26, 2007
Enrollment StartMay 1, 2007
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 19.3 years ago
Interventions
5-Azacytidinedrug
Valproic Aciddrug
ATRAdrug