NCT00003808

Theophylline in Treating Patients With In Situ, Stage I, or Stage II Chronic Lymphocytic Leukemia

Phase II Study of Theophylline in Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 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 theophylline in treating patients who have in situ, stage I, or stage II chronic lymphocytic leukemia.

Detailed description

OBJECTIVES: I. Determine the response rate in asymptomatic patients with stage 0, I, or II B-cell chronic lymphocytic leukemia treated with theophylline. II. Determine the toxicity of this treatment in these patients. OUTLINE: Patients receive oral theophylline daily. Daily treatment continues for a maximum of 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months for 1 year. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study over approximately 10 months.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	theophylline

Timeline

• Start date: 1999-08-11
• Primary completion: 2002-09-01
• First posted: 2004-07-22
• Last updated: 2023-06-22

Locations

71 sites across 3 countries: United States, Puerto Rico, South Africa