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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)

Primary Purpose

Lymphocytic Leukemia

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Genasense® (, oblimersen sodium G3139)
Sponsored by
Genta Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphocytic Leukemia focused on measuring Evaluate the Effect of Genasense on the Efficacy/Safety of Rituximab/Fludarabine Treatment in Untreated Subjects With Chronic Lymphocyctic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 14, 2007
    Last Updated
    February 7, 2008
    Sponsor
    Genta Incorporated
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00517218
    Brief Title
    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)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2007
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2009 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Genta Incorporated

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphocytic Leukemia
    Keywords
    Evaluate the Effect of Genasense on the Efficacy/Safety of Rituximab/Fludarabine Treatment in Untreated Subjects With Chronic Lymphocyctic Leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Genasense® (, oblimersen sodium G3139)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Learn more about this trial

    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)

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