Status:
COMPLETED
Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
Astex Pharmaceuticals, Inc.
Conditions:
B-Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Rationale: Research indicates that both cyclophosphamide and pentostatin work synergistically against cancer cells and have a high response rate against chronic lymphocytic leukemia (CLL) without crea...
Eligibility Criteria
Inclusion
- Diagnosis of B-CLL (no mantle cell)
- Must have active disease
- Age \>=18 yo
- ECOG 0-3
- No radiation or surgery \<4 weeks
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00201721
Start Date
July 1 2002
End Date
September 1 2006
Last Update
February 8 2017
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210