Status:
UNKNOWN
Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.
Lead Sponsor:
East Valley Hematology and Oncology Medical Group
Collaborating Sponsors:
Mena, Raul, M.D.
Pharmatech Oncology
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 drug...
Detailed Description
Chronic Lymphocytic Leukemia (CLL) is the most common form of adult leukemia in the U.S. Recent experience with Nipent in conjunction with Rituxan has shown that this combination is well tolerated and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2009
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00131313
Start Date
January 1 2003
End Date
April 1 2009
Last Update
August 18 2005
Active Locations (52)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, United States, 35661
2
East Valley Hematology and Oncology Medical Group
Burbank, California, United States, 91505
3
Bay Area Cancer Research Group
Concord, California, United States, 94520
4
Lalita Pandit, MD, Inc.
Fountain Valley, California, United States, 92708