Clofarabine and Cytarabine in Treating Older Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes That Have Relapsed or Not Responded to Treatment
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Myelodysplastic Syndrome With Isolated Del(5q)
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Myeloid Leukemia
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Oral Clofarabine Plus Low-dose Cytarabine in Previously Treated AML and High-Risk MDS Patients at Least 60 Years of Age|
- Safety, according to the National Cancer Institute (NCI) Common Terminology Criteria v3.0, as assessed by the MTD of clofarabine when given together with cytarabine [ Time Frame: Occurring by day 30 ] [ Designated as safety issue: Yes ]Dose limiting toxicity (DLT) consists of grade 3-4 non-hematologic toxicity at least possibly related to study drug. Exceptions include neutropenic fever; drug-related fever; alopecia; anorexia; inadequately treated nausea, vomiting and/or diarrhea; and grade 3/4 increase in ALT, AST, or bilirubin recovering to < grade 2 by 7 days. Prolonged grade 2 myelosuppression lasting longer than 49 days in patients who don't proceed to additional cytotoxic therapy is considered a DLT. The MTD or recommended phase II dose is the highest dose level at which no more than 1 patient out of 6 experiences DLT.
- Overall response [ Time Frame: Every 3 months for 2 years and then annually for 3 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Every 3 months for 2 years and then annually for 3 years ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: Every 3 months for 2 years and then annually for 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemotherapy)
Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: cytarabine
I. To estimate the maximum tolerated dose (MTD) of oral clofarabine when given with LDAC (cytarabine) in patients age >= 60 with previously treated AML or high risk MDS.
I. To determine the response rate, disease-free survival (DFS), and overall survival (OS) after therapy with oral clofarabine and LDAC for previously treated AML or high-risk MDS.
OUTLINE: This is a phase I, dose-escalation study of clofarabine followed by a phase II study.
Patients receive clofarabine orally (PO) once daily (QD) on days 1-5 and low-dose cytarabine subcutaneously (SC) twice daily (BID) on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then annually for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839982
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||John Pagel||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|