Study of Clofarabine & Cytosine Arabinoside Therapy for Older Adults With Acute Myeloid Leukemia
The purpose of this study is to determine the recommended phase II dose of clofarabine when administered in combination with standard dose Ara-C to older (>=60 years of age) patients with newly diagnosed acute myeloid leukemia (AML).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Clofarabine & Cytosine Arabinoside Therapy for Older Adults With Acute Myeloid Leukemia|
- Median time to complete response (CR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- To evaluate quality of life parameters before, during and after therapy in the older adult (>60 years) population [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Study Completion Date:||August 2011|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Clofarabine + Ara-C
An initial dose escalation of clofarabine with a fixed standard dose of Ara-C in phase I will be used to determine an optimal phase II dose.
Clofarabine should be administered by daily intravenous infusion over 2 hours.Following demonstration of DLT at Dose Level -I (22.5 mg/m2/day days 2-6) and demonstration that Dose Level -II (15mg/m2day days 2-6) is the 'optimal phase II dose', an additional Dose Level -1½ (20mg/m2/day, days 2-6) will be added to explore an increased dose of clofarabine intermediate between Dose Levels -I and -II.
Other Name: CLOFAREX TMDrug: Ara-C
Ara-C: Administer Ara-C by continuous infusion of 100mg/m2/day on days 1 to 7 for cycle 1, and on days 1 to 5 for cycles 2 & 3.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00081822
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|United States, Nebraska|
|The University of Nebraska|
|Omaha, Nebraska, United States, 68198|
|United States, Ohio|
|The Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||James M Foran, MD||University of Alabama at Birmingham|