CRUSH!!MDS 

Title: Phase 2 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) versus Azacitidine (AZA; 75 mg/m2 SC/IV daily for 5 days every month) in MDS Patients with Low and Intermediate-1 Risk Disease Transfusion-Dependent versus Best Supportive Care (BSC) in MDS   Patients with Low and Intermediate-1 Risk Disease Transfusion-Independent (Study 2014-0112)

Principal Investigator: Dr. Gail Roboz
Research Nurse: Yulia Dault, RN
Phone: (212) 746-4829
Email: yud9001@med.cornell.edu
Sponsor: MD Anderson Cancer Center 

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

Key Eligibility:

• Men & women 18 years or older
• De Novo or Secondary IPSS Low or Intermediate-1 risk MDS,
  including CMML-1
• ECOG < 3 at study entry
• Serum Creatinine < 2 mg/dL x ULN
• Total Bilirubin < 2 x ULN
• ALT/AST < 2 x ULN

Disease Status: Low and Intermediate Risk MDS
Study Status: Open
IRB#: 1412015747
Expiration: May 31, 2017