2 Arm Study of Clofarabine IV in MDS Patients

Completed · Phase 2

Conditions studied: Myelodysplastic Syndrome, Leukemia

In brief

The goal of this clinical research study is to compare the effectiveness of 2 different doses of the drug clofarabine that can be given on a weekly schedule for the treatment of Myelodysplastic Syndrome (MDS). The safety of these two doses will also be compared. Primary Objective: Compare the response rates of two dose schedules of clofarabine in MDS. Secondary Objective: Compare response durations, survivals and side effects of the two schedules.

Key facts

Study ID

NCT00422032

Run by

M.D. Anderson Cancer Center

People needed

60

Starts

2006-01-01

Expected to finish

2011-11-01

Last updated by the study team

2012-07-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with MDS and >/= 5% blasts or International Prognostic Scoring System (IPSS) risk intermediate or high; patients with Chronic Myelomonocytic Leukemia (CMML).
• No prior intensive chemotherapy or high-dose ara-C (> 1g/m2).
• Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.
• Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
• Hydroxyurea is permitted for control of counts prior to treatment.
• Procrit, GCSF are allowed before therapy.
• Performance 0-2 (Eastern Cooperative Oncology Group (ECOG)). Adequate organ function including the following: Adequate liver function (bilirubin of < 2mg/dl), and renal function (creatinine < 2mg/dl), and SGPT (ALT) < 3 * upper limit of normal (ULN). Adequate cardiac functions (New York Heart Association (NYHA) cardiac III-IV excluded).
• Signed informed consent.

You may not qualify if…

• Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Active and uncontrolled infections.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
• Prior clofarabine treatment.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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