Oral Clofarabine Study in Patients With Myelodysplastic Syndrome

Completed · Phase 2

Conditions studied: Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia

In brief

The goal of this clinical research study is to learn if clofarabine given by mouth on a weekly schedule can help to control MDS. The safety of clofarabine given by mouth will also be studied.

Key facts

Study ID

NCT00299156

Run by

M.D. Anderson Cancer Center

People needed

65

Starts

2006-03-01

Expected to finish

2012-12-01

Last updated by the study team

2015-11-03

Who can join

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

You may qualify if…

• Patients with MDS and >/= 5% blasts or 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 (ECOG). Adequate organ function including the following:Adequate liver function (bilirubin of < 2mg/dl), and renal function (creatinine < 2mg/dl), and SGPT (ALT) < 3 X ULN. Adequate cardiac functions (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. Child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. 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

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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