Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.

• Status: Unknown status
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: East Valley Hematology and Oncology Medical Group
• Collaborators: Astex Pharmaceuticals; Astex Pharmaceuticals, Inc.; Mena, Raul, M.D.; Pharmatech Oncology
• Treatments: Cyclophosphamide; Pentostatin; Rituximab

Criteria

Inclusion Criteria:

• Stage II, III or IV Chronic Lymphocytic Leukemia

• Disease requires chemotherapeutic treatment

• CT or MRI scan confirming measurable tumor size

• Documentation of CD markers

• Up to one prior treatment regimen

• Expected survival greater than 6 months

• ECOG performance status of 0-2

• Adequate renal, bone marrow and liver functions

• Negative pregnancy test (females of childbearing potential)

• Must agree to use acceptable birth control, if fertile

• Must complete Informed Consent

• No heart disease and must have adequate cardiac function

• Must test negative for viral Hepatitis B and C

Exclusion Criteria:

• More than one prior treatment for Chronic Lymphocytic Leukemia

• Known sensitivity to Nipent, Rituxan or Cytoxan or any component of these drugs

• Known HIV or AIDS illness

• Thyroid disease requiring medication

• History of any malignancy that could affect the diagnosis or assessment of the study treatment

• Pregnancy or breast feeding

• Evidence of Hepatitis B or C infection

• Inability to comply with the requirements of the study