This Study is Being Performed to Evaluate the Effect of Genasense on the Efficacy and the Safety of Rituximab/Fludarabine Combination Treatment in Previously Untreated Subjects With Chronic Lymphocyctic Leukemia(CLL)
Phase 3
Withdrawn
- Conditions
- Lymphocytic Leukemia
- Registration Number
- NCT00517218
- Lead Sponsor
- Genta Incorporated
- Brief Summary
To compare the efficacy and safety of combination treatment with Genasense, fludarabine, and rituximab versus combination treatment with fludarabine and rituximab in previously untreated subjects with CLL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Previously untreated subjects with intermediate-or high-risk CLL(modified Rai Stages I-IV)
- Measurable disease as primarily established by the National Cancer Institute-sponsored Working Group(NCI-WG) Guidelines for the diagnosis of CLL
- Requiring therapy for active disease, as primarily defined by the NCI-WG Guidelines
- Eastern Cooperative Oncology Group Performance Status < 2
- Adequate organ function determined , 14 days prior to the first dose of study medication
Exclusion Criteria
- Absolute Lymphocyte count > 100,000/uL
- Prior chemotherapy or other therapy for CLL, including allogeneic transplant
- Less than 3 weeks from any prior major surgery at the time of informed consent
- Failure to recover from any serious adverse effect of surgery
- History of autoimmune hemolytic anemia or autoimmune thrombocytopenia
- Active serious infection requiring systemic anti-infective therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method