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


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphocytic Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

GL305

NCT ID:

NCT00517218

Start Date:

June 2006

Completion Date:

June 2009

Related Keywords:

  • Lymphocytic Leukemia
  • Evaluate the Effect of Genasense on the Efficacy/Safety of Rituximab/Fludarabine Treatment in Untreated Subjects With Chronic Lymphocyctic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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