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)

Lymphocytic Leukemia Clinical Trial

Official title:

A Randomized Phase 3 Study of Fludarabine and Rituximab With or Without Genasense® (Oblimersen Sodium) in Previously Untreated Subjects With Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00517218
• Other study ID #: GL305
• Status: Withdrawn
• Phase: Phase 3
• First received: August 14, 2007
• Last updated: February 7, 2008
• Start date: June 2006
• Est. completion date: June 2009

Study information

• Verified date: August 2007
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphocytic Leukemia

Intervention

Drug:
• Genasense® (, oblimersen sodium G3139)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated