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

Status unconfirmed · Phase 4

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT00131313

Run by

East Valley Hematology and Oncology Medical Group

People needed

180

Starts

2003-01-01

Expected to finish

2009-04-01

Last updated by the study team

2005-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• East Valley Hematology and Oncology Medical Group — Burbank, California, United States (enrolling)
• Bay Area Cancer Research Group — Concord, California, United States (enrolling)
• Lalita Pandit, MD, Inc. — Fountain Valley, California, United States (enrolling)
• Pacific Coast Hematology/Oncology Medical Group, Inc. — Fountain Valley, California, United States (enrolling)
• Robert A. Moss, M.D. FACP, Inc. — Fountain Valley, California, United States (enrolling)
• Metropolitan Hematology Oncology Medical Group — Los Angeles, California, United States (enrolling)
• North County Oncology — Oceanside, California, United States (enrolling)
• Ventura County Hematology Oncology Specialists — Oxnard, California, United States (enrolling)
• Cancer and Blood Institute Medical Group — Rancho Mirage, California, United States (enrolling)
• St. Teresa Comprehensive Cancer Center — Stockton, California, United States (enrolling)
• Medical Group of North County — Vista, California, United States (enrolling)
• The Oncology Clinic, PC — Colorado Springs, Colorado, United States (enrolling)
• Mile High Oncology — Denver, Colorado, United States (enrolling)
• Palm Beach Institute of Hematology and Oncology — Boynton Beach, Florida, United States (enrolling)
• Integrated Community Oncology Network — Jacksonville, Florida, United States (enrolling)
• Osceola Cancer Center — Kissimmee, Florida, United States (enrolling)
• Pasco Hernando Oncology Associates, PA — New Port Richey, Florida, United States (enrolling)
• Pasco Pinellas Cancer Center — New Port Richey, Florida, United States (enrolling)
• Augusta Oncology Associates, PC — Augusta, Georgia, United States (enrolling)
• Spalding Oncology Services — Griffin, Georgia, United States (enrolling)
• St Luke's Mountain States Tumor Institute — Boise, Idaho, United States (enrolling)
• Oncology Hematology Assoc. of Northern Illinois — Gurnee, Illinois, United States (enrolling)
• Indiana Oncology Hematology Consultants — Indianapolis, Indiana, United States (enrolling)
• Arnett Cancer Care — Lafayette, Indiana, United States (enrolling)
• Northwest Alabama Cancer Center, PC — Muscle Shoals, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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