Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia
NCT ID: NCT00513305
Last Updated: 2012-08-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
67 participants
INTERVENTIONAL
2007-10-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low-dose cytarabine plus arsenic trioxide
Cycle 1 cytarabine 10 mg/m\^2 was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2 A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m\^2 sc bid on days 1 through 7 of a 28-day cycle.
Arsenic trioxide
Arsenic trioxide will be administered intravenously (iv) at a dose of 0.25 mg/kg.
Low-dose cytarabine alone
Cytarabine will be administered at a dose of 10 mg/m\^2 subcutaneously (sc) twice a day (bid).
Low-dose cytarabine alone
Cytarabine was administered at a dose of 10 mg/m\^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine was given to patients with persistent disease. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. Recovery period up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m\^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
Low-dose cytarabine alone
Cytarabine will be administered at a dose of 10 mg/m\^2 subcutaneously (sc) twice a day (bid).
Interventions
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Arsenic trioxide
Arsenic trioxide will be administered intravenously (iv) at a dose of 0.25 mg/kg.
Low-dose cytarabine alone
Cytarabine will be administered at a dose of 10 mg/m\^2 subcutaneously (sc) twice a day (bid).
Eligibility Criteria
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Inclusion Criteria
* The patient is unwilling or unable to tolerate conventional induction chemotherapy.
* The patient has no comorbid conditions that would limit life expectancy to less than 3 months.
* Patient must meet specific laboratory parameters for study inclusion.
Exclusion Criteria
Previous treatment with low-dose cytarabine is not permitted.
* The patient has a QT interval outside of the protocol-specified range.
* The patient has laboratory values outside of protocol-specified ranges.
* The patient is concurrently treated with cytotoxic therapy, radiation, or investigational agents.
* The patient has uncontrolled, severe cardiovascular or pulmonary disease or other uncontrolled medical condition.
* The patient has known central nervous system involvement with AML.
60 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Responsible Party
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Locations
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USC / Norris Cancer Hospital
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
University of Illinois
Chicago, Illinois, United States
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Brody School of Medicine
Greenville, North Carolina, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UT Health Science Center
San Antonio, Texas, United States
Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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C18477/3059/AM/US-CA
Identifier Type: -
Identifier Source: org_study_id