Status:
COMPLETED
Genasense® (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects With Chronic Lymphocytic Leukemia
Lead Sponsor:
Genta Incorporated
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The treatment combination of Rituxan® (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. However, ...
Eligibility Criteria
Inclusion
- Key
- Absolute lymphocyte count of \> 10,000 cells/mm3 or history of ALC \>10,000 cell/mm3
- Platelets \> 50,000 cells/mm3
- Tumor lymphocytes expressing surface CD5, CD19, CD20 and CD23
- Creatinine \< 1.5 mg.dL
- Key
Exclusion
- Less than 3 weeks from any prior major surgery or other therapy for CLL including radiation therapy, chemotherapy, high-dose steroid therapy, immunotherapy, cytokine, biologic or vaccine therapy.
- History of autoimmune hemolytic anemia
- Prior allogeneic transplant
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00078234
Start Date
November 1 2003
End Date
September 1 2010
Last Update
November 7 2011
Active Locations (3)
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1
Georgetown University Medical Center/Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20007
2
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
3
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040