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Genasense® (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects With Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT00078234
First received: February 20, 2004
Last updated: November 4, 2011
Last verified: May 2009
History of Changes
  Purpose

The treatment combination of Rituxan® (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. However, some leukemia subjects continue to have leukemia despite treatment with these standard anticancer drug therapies, or they may work for only a short period of time. In some subjects, when the leukemia does not respond well to therapy the leukemia cells may be over-producing one or more proteins. One of these proteins is called Bcl-2. Bcl-2 is a protein that appears to protect cancer cells from being killed and thus lengthens the life of the cancer cells. Genasense® (oblimersen sodium) is a compound that blocks production of the Bcl-2 protein. By first lowering levels of Bcl-2, it is possible that chemotherapy drugs may work more effectively as a cancer treatment. Genasense® may also directly kill CLL cells. This study will test whether treating subjects with Genasense®, fludarabine and rituximab is safe and effective.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
 Drug: Oblimersen-rituximab-fludarabine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Genasense® (G3139, Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated Subjects With Chronic Lymphocytic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • Safety and complete response rate [ Time Frame: Monthly for response ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: November 2003
Study Completion Date: September 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Oblimersen-rituximab-fludarabine
    28-day cycles; Cycle 1: oblimersen by continuous IV infusion 1.5 mg/kg/d for 7 consecutive days, completing on Day 8; rituximab by IV infusion on Day 4 (125 mg/m2) and Day 6 (250 mg/m2); fludarabine 25 mg/m2 by IV infusion for 3 days, starting on Day 6. Subsequent cycles: oblimersen 3 mg/kg/d, completing on Day 8; rituximab 375 mg/m2 on Day 5; fludarabine 25 mg/m2 for 3 days starting the same day as rituximab
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Absolute lymphocyte count of > 10,000 cells/mm3 or history of ALC >10,000 cell/mm3
  • Platelets > 50,000 cells/mm3
  • Tumor lymphocytes expressing surface CD5, CD19, CD20 and CD23
  • Creatinine < 1.5 mg.dL

Key Exclusion Criteria:

  • Less than 3 weeks from any prior major surgery or other therapy for CLL including radiation therapy, chemotherapy, high-dose steroid therapy, immunotherapy, cytokine, biologic or vaccine therapy.
  • History of autoimmune hemolytic anemia
  • Prior allogeneic transplant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00078234

Locations
United States, District of Columbia
Georgetown University Medical Center/Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Genta Incorporated
  More Information

Additional Information:
Genta's website/ centerwatch.com - Trial # 54371  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT00078234     History of Changes
Other Study ID Numbers: GL217
Study First Received: February 20, 2004
Last Updated: November 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genta Incorporated:
CLL
Leukemia
Chronic
Cancer
Adult
Lymphocytic
Genasense
 G3139
Genta
Bcl-2
Antisense
Oligonucleotide
oblimersen

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 June 18, 2013