Acute Myeloid Leukemia Clinical Trial

Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

The patient has confirmed acute myeloid leukemia (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 acute myeloid leukemia (AML) or myelodysplastic syndrome (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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

67

Study ID:

NCT00513305

Recruitment Status:

Terminated

Sponsor:

Cephalon

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There are 12 Locations for this study

See Locations Near You

USC / Norris Cancer Hospital
Los Angeles California, 90033, United States
UCLA Medical Center
Los Angeles California, 90095, United States
University of Illinois
Chicago Illinois, 60612, United States
Indiana Oncology Hematology Consultants
Indianapolis Indiana, 46202, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
St. Vincent's Comprehensive Cancer Center
New York New York, 10011, United States
Weill Medical College of Cornell University
New York New York, 10021, United States
Brody School of Medicine
Greenville North Carolina, 27834, United States
University of Oklahoma
Oklahoma City Oklahoma, 73104, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
UT Health Science Center
San Antonio Texas, 78229, United States
Princess Margaret Hospital
Toronto Ontario, M5G2M, Canada

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

67

Study ID:

NCT00513305

Recruitment Status:

Terminated

Sponsor:


Cephalon

How clear is this clinincal trial information?

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