Oral Clofarabine Study in Patients With Myelodysplastic Syndrome
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Genzyme
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00299156
First received: March 3, 2006
Last updated: December 10, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia |
Drug: Clofarabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Oral Clofarabine in Myelodysplastic Syndrome (MDS) |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Complete Response Rate (CR Rate) [ Time Frame: After 3 courses of therapy ] [ Designated as safety issue: No ]Response rate is calculated as number of participants with Complete Remission (CR) divided by total number of participants after 3 courses of oral clofarabine therapy where CR is Normalization of the peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 109/ L, and a platelet count > 100 x 109/L). Monitored using the Bayesian approach of Thall, Simon, Estey (1995, 1996) and the extension by Thall and Sung (1998).
| Enrollment: | 65 |
| Study Start Date: | March 2006 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Oral Clofarabine
10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
|
Drug: Clofarabine
Starting dose 10 mg (Group 1) or 20 mg (Group 2) as tablets once a day for 5 days in a row and repeated every 4-8 weeks. Each 4-8 week period is a cycle.
Other Names:
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with MDS and >/= 5% blasts or IPSS risk intermediate or high; patients with 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299156
Locations
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genzyme
Investigators
| Principal Investigator: | Hagop Kantarjian, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00299156 History of Changes |
| Other Study ID Numbers: | 2005-0536 |
| Study First Received: | March 3, 2006 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Myelodysplastic Syndrome MDS Chronic Myelomonocytic Leukemia CMML |
Clofarabine Clofarex Clolar Chemotherapy |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Preleukemia Leukemia, Myelomonocytic, Acute Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid |
Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Clofarabine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013