Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide, to monitor and assess toxicity of this regimen, and to determine the overall and progression-free survival in CLL patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Byrd; Ohio State University Comprehensive Cancer Center
• Collaborators: Astex Pharmaceuticals; Astex Pharmaceuticals, Inc.
• Treatments: Cyclophosphamide; Pentostatin; Rituximab

Criteria

Inclusion Criteria:

• Diagnosis of B-CLL (no mantle cell)

• Must have active disease

• Age >=18 yo

• ECOG 0-3

• No radiation or surgery <4 weeks

Exclusion Criteria:

• Any of the following comorbid conditions:

• New York Heart Association Class III or IV heart disease

• Recent myocardial infarction (<1 month)

• Uncontrolled infection

• Active infection with the human immunodeficiency virus (HIV/AIDS) as further severe immunosuppression with this regimen may occur.

• Pregnant or nursing women

• Men or women of child bearing potential must use adequate contraception.

• Active primary malignancy requiring treatment or limits survival to ≤2 years.

• Any radiation therapy ≤4 weeks prior to study entry.

• Any major surgery ≤4 weeks prior to study entry.