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. GenasenseTM (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	Treatment or Intervention
Chronic Lymphocytic Leukemia	Drug: Oblimerson sodium, G3139  Drug: Fludarabine  Drug: Rituximab

Further Study Details: 

Expected Total Enrollment:  80

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Key Inclusion Criteria:

• Absolute lymphocyte count of > 10,000 cells/mm3 for untreated subjects. Previously treated subjects must have a history of an absolute count of > 10,000 cells/mm3
• Platelets > 50,000 cells/mm3
• Creatinine < 1.5 mg/dL

Key Exclusion Criteria:

• Less than 3 weeks from any prior major surgery or other surgery including radiation therapy, chemotherapy, immunotherapy, high-dose steroid therapy, cytokine, biologic or vaccine therapy for those subjects who were previously treated.
• History of autoimmune hemolytic anemia
• Prior allogeneic transplant

District of Columbia
      Georgetown University Medical Center/Lombardi Cancer Center, Washington,  District of Columbia,  20007,  United States; Recruiting
New York
      Long Island Jewish Medical Center, New Hyde Park,  New York,  11040,  United States; Recruiting
      Roswell Park Cancer Institute, Buffalo,  New York,  14263,  United States; Recruiting

Study ID Numbers:  GL217
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  February 20, 2004
ClinicalTrials.gov Identifier:  NCT00078234
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08