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Title Phase II Randomized Study of Lower Doses of Decitabine (DAC; 20mg/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

IRB MDCC1914

CC 14-1479

Hospital Fairview, Hillcrest, Independence, Main Campus, Mansfield, North Coast Cancer, South Pointe, Strongsville, Wooster

Phase Phase 2

Disease Myelodisplastic Syndrome (MDS)

Drug Azacitidine, Decitabine

Description

• Compare the event-free survival rates of two different drugs: DAC versus AZA on an abbreviated schedule to a standard arm of AZA given over 5 days in patients with low-risk MDS transfusion-dependent and to BSC in patients with low-risk MDS transfusion-independent.

• Compare the response rates for the transfusion independent and the transfusion dependent patients. For example the response rate of two different drugs DAC versus AZA on abbreviated schedule to a standard arm of AZA given over 5 days.
• Evaluate the durability of response, the overall and transformation-free survival rates, and the safety profile of 2 different drugs.

Inclusion Criteria

• Sign an IRB-approved informed consent document.
• Age ≥ 18 years.
• de novo or secondary IPSS low- or intermediate-1-risk MDS, including CMML-1
• ECOG performance status of ≤ 3 at study entry.
  • Serum creatinine ≤ 2 mg/dL
  • Total bilirubin ≤ 2 x ULN
  • ALT (SGPT) ≤ 2 x ULN
  • AST (SGOT) </= 2 x ULN
• Woman 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

• Breast feeding females
• Prior therapy with decitabine or azacitidine