Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT00006092
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.
Detailed Description:
OBJECTIVES:
* Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide.
* Determine the duration of hematologic response and overall survival of these patients when treated with this regimen.
* Determine the pattern of clinical adverse experience in these patients when treated with this regimen.
* Determine the pharmacokinetic profile of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course.
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 24-49 patients will be accrued for this study within 2.5 years.
Study:
NCT00006092
Study Brief:
Protocol Section:
NCT00006092