Clinical Trial 18083

Cancer Type: Malignant Hematology
Interventions:azacitidine (5-azacitidine); decitabine (5-aza-2'-deoxycytidine)

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Rami Komrokji

Overview

Study Title

Phase II Randomized Study of Lower Doses of Decitabine (DAC; 20 mg/m^2 IV daily for 3 days every month) versus Azacitidine (AZA; 75 mg/m^2 SC/IV daily for 3 days every month) versus Azcitidine (AZA; 75 mg/m^2 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

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.

Objective

Primary: 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. Secondary: 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 greater than or equal to 18 years.
  • de novo or secondary IPSS low- or intermediate-1-risk MDS, including CMML-1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 3 at study entry.
  • Adequate organ function.
  • 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

    >>>

  • Women who are pregnant or breast feeding.
  • Prior therapy with decitabine or azacitidine.