Clinical trial NCT00513305: Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia, cytarabine, arsenic trioxide.
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2007-08-08
Enrollment: 67
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants in Complete Remission (CR)
timeFrame: 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
Secondary outcomes:
measure: Number of Participants Who Died or Were Censored by 24 Months
timeFrame: From Baseline through 24 months following Baseline
measure: Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate
timeFrame: From Baseline (randomization) through 24 months following Baseline
measure: Number of Participants Who Experienced Early Death
timeFrame: 14 days from start of study drug treatment
measure: Number of Participants Who Experienced Induction (Thirty-Day) Mortality
timeFrame: Up to 30 days following start of study drug treatment
measure: Proportion of Participants Surviving at 6 Months and 12 Months Using the Kaplan Meier Estimate
timeFrame: Baseline through 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Cancer Hospital
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Oncology Hematology Consultants
state: Indiana
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: St. Vincent's Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Greenville
country: United States
facility: Brody School of Medicine
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: San Antonio
country: United States
facility: UT Health Science Center
state: Texas
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
References: