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

Sponsor:	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-rituximab-fludarabine	Phase I Phase II

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

Resource links provided by NLM:

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

Drug Information available for: Fludarabine Fludarabine monophosphate Rituximab Oblimersen sodium

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 ]

Estimated Enrollment:	32
Study Start Date:	November 2003
Estimated Study Completion Date:	September 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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
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

Additional Information:

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

No publications provided

Responsible Party:	Genta Incorporated ( Steven Novick, MD )
Study ID Numbers:	GL217
Study First Received:	February 20, 2004
Last Updated:	May 22, 2009
ClinicalTrials.gov Identifier:	NCT00078234 History of Changes
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:

Antimetabolites
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Fludarabine monophosphate

Immunosuppressive Agents
Pharmacologic Actions
Leukemia
Lymphatic Diseases
Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Fludarabine
Antirheumatic Agents
Leukemia, B-Cell
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on November 09, 2009