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)

NCT ID: NCT00517218

Last Updated: 2008-02-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-06-30

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.

Conditions

Lymphocytic Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Genasense® (, oblimersen sodium G3139)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genta Incorporated

INDUSTRY

Sponsor Role: lead

Other Identifiers

GL305

Identifier Type: -

Identifier Source: org_study_id