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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517218
Recruitment Status : Withdrawn
First Posted : August 16, 2007
Last Update Posted : February 11, 2008
Information provided by:
Genta Incorporated

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.

Condition or disease Intervention/treatment Phase
Lymphocytic Leukemia Drug: Genasense® (, oblimersen sodium G3139) Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2006
Study Completion Date : June 2009

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 Identifier: NCT00517218     History of Changes
Other Study ID Numbers: GL305
First Posted: August 16, 2007    Key Record Dates
Last Update Posted: February 11, 2008
Last Verified: August 2007

Keywords provided by Genta Incorporated:
Evaluate the Effect of Genasense on the Efficacy/Safety of Rituximab/Fludarabine Treatment in Untreated Subjects With Chronic Lymphocyctic Leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine phosphate
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents