Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT00513305 |
Recruitment Status :
Terminated
(Study has been stopped by sponsor decision)
First Posted : August 8, 2007
Results First Posted : March 29, 2011
Last Update Posted : August 1, 2012
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Sponsor:
Cephalon
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
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Tracking Information | |||
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First Submitted Date ICMJE | August 6, 2007 | ||
First Posted Date ICMJE | August 8, 2007 | ||
Results First Submitted Date ICMJE | July 29, 2010 | ||
Results First Posted Date ICMJE | March 29, 2011 | ||
Last Update Posted Date | August 1, 2012 | ||
Study Start Date ICMJE | October 2007 | ||
Actual Primary Completion Date | July 2009 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Percentage of Participants in Complete Remission (CR) [ Time Frame: From baseline through Day 70. Assessments were performed on Day 21 in cycle 1, no later than Day 56 of cycle 1 or 2 (if applicable), and no later than Day 70 of cycle 1 or 2 (if applicable) or at any other time at the discretion of the investigator ] The primary efficacy variable was the percentage of subjects in each treatment group who achieved complete remission after treatment with study drug. Complete remission was defined as: 1) Less than 5% blasts in normocellular bone marrow sample. 2) No blasts in bone marrow sample containing Auer rods. 3)Clearance of previous extramedullary disease. 4)Normal values for absolute neutrophil count (at least 1000/microliter), platelet count (at least 100,000/microliter), without platelet transfusions, and in absence of peripheral myeloblasts.
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Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia | ||
Official Title ICMJE | An Open-Label, Randomized Study of Low-Dose Cytarabine in Combination With Arsenic Trioxide Compared With Low-Dose Cytarabine Alone for the Treatment of Elderly Patients With Acute Myeloid Leukemia | ||
Brief Summary | The primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Acute Myeloid Leukemia | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Terminated | ||
Actual Enrollment ICMJE |
67 | ||
Original Estimated Enrollment ICMJE |
210 | ||
Actual Study Completion Date ICMJE | December 2009 | ||
Actual Primary Completion Date | July 2009 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - The patient has had previous cytotoxic chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Previous treatment with low-dose cytarabine is not permitted.
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Canada, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00513305 | ||
Other Study ID Numbers ICMJE | C18477/3059/AM/US-CA | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Teva Pharmaceutical Industries ( Cephalon ) | ||
Study Sponsor ICMJE | Cephalon | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Teva Pharmaceutical Industries | ||
Verification Date | July 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |