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

Phase 3TerminatedNCT00513305

Cephalon67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

Arsenic trioxideDRUG

Arsenic trioxide will be administered intravenously (iv) at a dose of 0.25 mg/kg.

Low-dose cytarabine aloneDRUG

Cytarabine will be administered at a dose of 10 mg/m\^2 subcutaneously (sc) twice a day (bid).

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (12)

USC / Norris Cancer Hospital

Los Angeles, California, United States

UCLA Medical Center

Los Angeles, California, United States

University of Illinois

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Percentage of Participants in Complete Remission (CR)

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.

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

Secondary Outcomes

Number of Participants Who Died or Were Censored by 24 Months

This measure (time to death or censor) was defined for all enrolled subjects from the date of randomization until death from any cause. If a subject was not known to have died by the end of the followup period, observation of overall survival was censored on the date the patient was last known to be alive. The number of participants who died or were censored is presented here. (Note: all subjects participating in this study had either died or were censored by 24 months.)

Time frame: From Baseline through 24 months following Baseline

Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate

RFS is defined for patients who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR), and was measured from the date of attaining CR, CRp, or PR until the date of AML relapse or death from any cause, whichever occurred first. For a patient not known to have relapsed or died by the end of the study followup, observation of relapse free survival was censored on the date of the last followup examination. The Kaplan Meier Estimate of relapse-free survival at Month 3 and Month 6 is presented here.

Time frame: From Baseline (randomization) through 24 months following Baseline

Data from ClinicalTrials.gov

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