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

NCT00513305 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2012-08-01

Study results available
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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.

Conditions

Interventions

DRUG

Arsenic trioxide

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

DRUG

Low-dose cytarabine alone

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

Sponsors & Collaborators

  • Cephalon

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-07-31
Completion
2009-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00513305 on ClinicalTrials.gov