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RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying clofarabine when given together with cytarabine to see how well they work in treating patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.
OBJECTIVES: * Determine the response rate in adult patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with high-dose cytarabine followed by clofarabine. OUTLINE: This is an open-label phase II study. Patients are stratified according to diagnosis (acute myeloid leukemia vs acute lymphoblastic leukemia Phase II: Patients receive high-dose cytarabine followed by clofarabine (at the dose determined in phase I) on days 1-3. After completion of study treatment, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 39 patients were accrued for this study.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Start Date
February 1, 2005
Primary Completion Date
November 1, 2008
Completion Date
November 1, 2008
Last Updated
June 20, 2017
39
ACTUAL participants
clofarabine
DRUG
cytarabine
DRUG
Lead Sponsor
Wake Forest University Health Sciences
Collaborators
NCT06311227
NCT06285890
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07388563