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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)

Sponsor
Genta Incorporated (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00517218
Collaborator
(none)
36
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Genasense® (, oblimersen sodium G3139)
 Phase 3

Study Design

Study Type:
Interventional
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 :
Jun 1, 2006
Study Completion Date :
Jun 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Genta Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00517218
    Other Study ID Numbers:
    • GL305
    First Posted:
    Aug 16, 2007
    Last Update Posted:
    Feb 11, 2008
    Last Verified:
    Aug 1, 2007
    Keywords provided by , ,
    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
    Leukemia, Lymphoid
    Oblimersen

    Study Results

    No Results Posted as of Feb 11, 2008