Status:
WITHDRAWN
Cyclophosphamide and Rituximab Followed By Vaccine Therapy in Treating Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal an...
Detailed Description
OBJECTIVES: * Determine the efficacy and toxicity of cyclophosphamide and rituximab in patients with previously untreated, high-risk chronic lymphocytic leukemia. * Determine, preliminarily, the effi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of chronic lymphocytic leukemia (CLL)
- Meets 1 of the following high-risk features:
- 17p deletion by fluorescent in situ hybridization (FISH)
- 11q deletion by FISH
- Unmutated immunoglobulin heavy chain variable region (IgVH) genes, defined as ≥ 98% homology with germline in a Clinical Laboratory Improvement Act (CLIA) approved laboratory
- Any stage disease
- Previously untreated disease
- Not requiring immediate treatment
- Absolute lymphocyte count ≥ 20,000/mm³
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2 mg/dL (unless secondary to obstructive cholestasis from lymphadenopathy or Gilbert's disease)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infections requiring oral or intravenous antibiotics
- No autoimmune disorder (e.g., autoimmune hemolytic anemia) requiring corticosteroids before the start of study vaccination
- No other malignancy except nonbasal cell skin cancer, carcinoma in situ of the cervix, or tumor that was treated with curative intent ≥ 2 years ago
- PRIOR CONCURRENT THERAPY:
- No prior therapy for CLL
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00343447
Start Date
August 1 2006
End Date
May 1 2007
Last Update
May 3 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410