CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 113 enrolled
Drug / intervention
Decitabine +1 moredrug
Likely dose
Decitabine 20 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/NCT01720225
NCT01720225Phase 2Completed

Phase II Randomized Study of Lower Doses of Decitabine (DAC; 20 mg/m2 IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 3 Days Every Month) in Myelodysplastic Syndrome (MDS) Patients With Low and Intermediate-1 Risk Disease

M.D. Anderson Cancer Center·interventional·Posted Nov 2, 2012·Updated Dec 24, 2020

In Brief

A Phase 2 clinical trial evaluating Decitabine and Azacitidine for Leukemia. Completed, enrolled 113 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to compare how two different drugs, decitabine and azacitidine, when given on a shorter than standard dosing schedule can help to control MDS. The safety of the drugs will also be studied. Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die. Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better. This could cause the cancer cells to die.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2012
Enrollment StartNov 6, 2012
Primary CompletionJan 8, 2020
TodayJul 1, 2026
Enrollment to primary: 7.2 yearsPosted 13.7 years ago

Interventions

Decitabinedrug

20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.

Azacitidinedrug

75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.