Overview

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

Status:
Active, not recruiting

Trial end date:
2026-10-30

Target enrollment:
0

Participant gender:
All

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. Up to 240 participants will be enrolled in this multicenter study. Up to 157 will take part at MD Anderson.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborators:

MDS Consortium
National Cancer Institute (NCI)

Treatments:

Azacitidine
Decitabine

Criteria

Inclusion Criteria:

1. Sign an IRB-approved informed consent document.

2. Age >/= 18 years.

3. IPSS low- or intermediate-1-risk MDS, including CMML-1

4. ECOG performance status of
5. Organ function defined as: Serum creatinine ALT (SGPT)
6. Women of childbearing potential must have a negative serum or urine pregnancy test
within 7 days and will also need to use contraceptives. Men must agree not to father a
child and agree to use a condom if his partner is of child bearing potential.

Exclusion Criteria:

1. Breast feeding females

2. Prior therapy with decitabine or azacitidine