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Study Summary
No. 2005-0536:.......Leukemia......Hagop Kantarjian......Leukemia
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Study Summary Title
Study Summary
Number:		2005-0536
Study Title:Phase II Study of Oral Clofarabine in Myelodysplastic Syndrome (MDS)
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Physician New Patient Referral
Name:Hagop KantarjianPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7305
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Every 4 to 8 weeks, up to a total of 12 courses of therapy; about 2 to 3 years.
Treatment
Agents:		ClofarabineHome Care:Self medicated
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		5 days
Description/
Intervention:		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.
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Study Objectives / Outcomes
Primary: Evaluate the response rate of oral clofarabine in MDS.

Secondary: Evaluate survival and side effects.
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Study Status Information
Study Activation / Registration Date:03/01/2006
IRB Review and Approval Date:10/19/2005
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients with MDS and >/= 5% blasts or IPSS risk intermediate or high; patients with CMML.

2) No prior intensive chemotherapy or high-dose ara-C (>/= 1g/m2).

3) Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.

4) 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.

5) Hydroxyurea is permitted for control of counts prior to treatment.

6) Procrit, GCSF are allowed before therapy.

7) 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).

8) Signed informed consent.
Exclusion Criteria:1) 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.

2) Active and uncontrolled infections.

3) 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.

4) Prior clofarabine treatment.
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Links
Registration Number: NCT00299156
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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