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Phase II Decitabine (DAC) Versus Azacitidine (AZA) in Myelodysplastic Syndrome (MDS)

NCT02269280 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2025-08-07

Study results available
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Summary

The goal of this clinical research study is to compare how 2 different drugs, decitabine and azacitidine, when given on a shorter than standard dosing schedule, may help to control MDS. The safety of each study drug given on these schedules will also be studied.

This is an investigational study. Decitabine and azacitidine are both FDA approved and commercially available for use in patients with MDS. Giving these drugs on a different schedule than is standard is considered investigational.

The study doctor can tell you how the study drugs are designed to work.

Conditions

Interventions

DRUG

Azacitidine (AZA) Days 1 - 3

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

DRUG

Decitabine (DAC)

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

OTHER

Best Supportive Care (BSC)

Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.

DRUG

Azacitidine (AZA) Days 1 - 5

Azacitidine 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Guillermo Garcia-Manero · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-13
Primary Completion
2024-07-25
Completion
2024-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02269280 on ClinicalTrials.gov