A Pilot Study of Genasense® (G3139, Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated Subjects With Chronic Lymphocytic Leukemia
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia
Both
Chronic Lymphocytic Leukemia
Trial Information
A Pilot Study of Genasense® (G3139, Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated Subjects With Chronic Lymphocytic Leukemia
Key
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and complete response rate
Outcome Time Frame:
Monthly for response
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
GL217
NCT ID:
NCT00078234
Start Date:
November 2003
Completion Date:
September 2010
Related Keywords:
- Chronic Lymphocytic Leukemia
- CLL
- Leukemia
- Chronic
- Cancer
- Adult
- Lymphocytic
- Genasense
- G3139
- Genta
- Bcl-2
- Antisense
- Oligonucleotide
- oblimersen
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
| Georgetown University Medical Center/Lombardi Cancer Center | Washington, District of Columbia 20007 |
