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

This study is ongoing, but not recruiting participants.

Sponsored by: Genta Incorporated
Information provided by: Genta Incorporated
ClinicalTrials.gov Identifier: NCT00078234
  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 sodium, G3139
Drug: Fludarabine
Drug: Rituximab
Phase I
Phase II

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic   

Drug Information available for:   Fludarabine    Fludarabine monophosphate    Rituximab    Oblimersen sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Genta Incorporated:

Estimated Enrollment:   32
Study Start Date:   November 2003

  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
Long Island Jewish Medical Center    
      New Hyde Park, New York, United States, 11040
Roswell Park Cancer Institute    
      Buffalo, New York, United States, 14263

Sponsors and Collaborators
Genta Incorporated
  More Information


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

Study ID Numbers:   GL217
First Received:   February 20, 2004
Last Updated:   April 26, 2007
ClinicalTrials.gov Identifier:   NCT00078234
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

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Rituximab
Leukemia, Lymphocytic, Chronic, B-Cell
Fludarabine
Fludarabine monophosphate
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:
Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 30, 2008




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