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 - Tabular View

Tracking Information
First Received Date ^ICMJE	August 6, 2007
Last Updated Date	June 30, 2009
Start Date ^ICMJE	October 2007
Estimated Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 1, 2008)	The primary objective is to determine whether low dose cytarabine (LDAC) in combination with arsenic trioxide is more effective than low dose cytarabine alone in achieving complete remission (CR) in elderly patients. [ Time Frame: up to 140 days + maintenance ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: November 2, 2007)	The primary objective is to determine whether low dose cytarabine (LDAC) in combination with arsenic trioxide is more effective than low dose cytarabine alone in achieving complete remission (CR) in elderly patients.
Change History	Complete list of historical versions of study NCT00513305 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 1, 2008)	Evaluate the safety of treatment with LDAC in combination with arsenic trioxide [ Time Frame: up to 140 days + maintenance ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: December 21, 2007)	Evaluate the safety of treatment with LDAC in combination with arsenic trioxide [ Time Frame: up to 126 days + maintenance ] [ Designated as safety issue: Yes ]

Descriptive Information
Brief Title ^ICMJE	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
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
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Condition ^ICMJE	Acute Myeloid Leukemia
Intervention ^ICMJE	Drug: Arsenic Trioxide and Low-Dose Cytarabine Drug: low-dose cytarabine (LDAC) plus arsenic trioxide
Study Arms / Comparison Groups	Active Comparator: low-dose cytarabine (LDAC) plus arsenic trioxide Active Comparator: low-dose cytarabine (LDAC) alone
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	67
Estimated Completion Date	February 2011
Estimated Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: The patient has confirmed AML. 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: The patient has had previous cytotoxic chemotherapy for AML or MDS. 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.
Gender	Both
Ages	60 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00513305
Responsible Party	Sponsor's Medical Expert, Cephalon
Study ID Numbers ^ICMJE	C18477/3059/AM/US-CA
Study Sponsor ^ICMJE	Cephalon
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cephalon
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP