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)

• Status: Withdrawn
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Genta Incorporated
• Treatments: Fludarabine; Fludarabine phosphate; Oblimersen; Rituximab

Criteria

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