CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 128 enrolled
Drug / intervention
Decitabine +2 moredrug
Likely dose
Decitabine 10 mg/m² IV daily for 10 days, or 20 mg/m² IV daily for 5 days, or 20 mg/m² SQ daily for 5 daysAI-extracted
Key inclusion· 7
  • ✓MDS with ≥5% marrow blasts OR IPSS intermediate-1/2 or high risk; or CMML
  • ✓ECOG performance status 0–2
  • ✓Adequate hepatic function: bilirubin <2 mg/dL
  • ✓Adequate renal function: creatinine <2 mg/dL
Key exclusion· 3
  • ✕Pregnant or nursing females
  • ✕Active and uncontrolled infections
  • ✕Uncontrolled intercurrent illness (ongoing/active infection, symptomatic congestive heart failure, unstable angina, psychiatric illness/social situations limiting compliance)

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

Search/NCT00067808
NCT00067808Phase 2Completed
CompareCT.gov

Phase II Randomized Study of Three Different Schedules of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) in Myelodysplastic Syndrome (MDS)

M.D. Anderson Cancer Center·interventional·Posted Aug 28, 2003·Updated Aug 7, 2012

In Brief

A Phase 2 clinical trial evaluating Decitabine for Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia. Completed, enrolled 128 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if decitabine (given at 3 different doses) can help to control Myelodysplastic Syndrome (MDS). The safety of these 3 treatments will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome, Chronic Myelomonocytic Leukemia
CountriesUnited States
CollaboratorsEisai Inc.

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 28, 2003
Enrollment StartOct 1, 2003
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 22.8 years ago

Interventions

Decitabinedrug

10 mg/m\^2 by vein over 1 hour daily for 10 days

Decitabinedrug

20 mg/m2 by vein (IV) over 1 hour daily x 5 days

Decitabinedrug

20 mg/m2 subcutaneous (SQ) daily x 5 days