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)

Genta Incorporated

Status and phase: Withdrawn; Phase 3

Conditions: Lymphocytic Leukemia

Treatments: Drug: Genasense® (, oblimersen sodium G3139)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00517218

GL305

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)