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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)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT00517218
First received: August 14, 2007
Last updated: February 7, 2008
Last verified: August 2007
History of Changes
  Purpose

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 Intervention Phase
Lymphocytic Leukemia
 Drug: Genasense® (, oblimersen sodium G3139)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genta Incorporated:

Study Start Date: June 2006
Estimated Study Completion Date: June 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00517218     History of Changes
Other Study ID Numbers: GL305
Study First Received: August 14, 2007
Last Updated: February 7, 2008
Health Authority: United States: Food and Drug Administration

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
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
Fludarabine monophosphate
Rituximab
 Vidarabine Phosphate
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 22, 2013