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

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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

This study is currently recruiting participants.
Information provided by Cephalon

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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 ^†

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 ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

Evaluate the safety of treatment with LDAC in combination with arsenic trioxide [ Time Frame: up to 140 days + maintenance ] [ Designated as safety issue: Yes ]

Condition ^†

Acute Myeloid Leukemia

Intervention ^†

Drug: Arsenic Trioxide and Low-Dose Cytarabine
Drug: low-dose cytarabine (LDAC) plus arsenic trioxide

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

210

Start Date ^†

October 2007

Completion Date

October 2012

Eligibility Criteria ^†

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

Contacts ^††

Contact: Cephalon Contact

1-877-CEPH-TRY

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00513305

Organization ID

C18477/3059/AM/US-CA

Secondary IDs ^††

Study Sponsor ^†

Cephalon

Collaborators ^††

Investigators ^†

Information Provided By

Cephalon

Verification Date

August 2008

First Received Date ^†

August 6, 2007

Last Updated Date

August 14, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.