NCT00012259

Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia

A Phase II Study Of Troxatyl In Patients With CML Blastic Phase Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 16 Years – 120 Years
• Healthy volunteers: Not accepted

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 troxacitabine in treating patients who have blast phase chronic myelogenous leukemia.

Detailed description

OBJECTIVES: I. Determine the response rate, in terms of achieving complete hematologic remission, partial hematologic remission, hematologic improvement, partial response, or back to chronic phase status, in patients with blastic phase chronic myelogenous leukemia treated with troxacitabine. II. Determine the proportion of patients whose disease returns to chronic phase and remains at that level for at least 3 months when treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Determine the duration of survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive troxacitabine IV over 30 minutes on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks until relapse. PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 14 months.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	troxacitabine

Timeline

• Start date: 2000-12-11
• Primary completion: 2002-03-27
• Completion: 2002-03-27
• First posted: 2004-02-26
• Last updated: 2021-06-10

Locations

20 sites across 2 countries: United States, Canada