Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.
A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.
2 other identifiers
interventional
180
1 country
52
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2003
Longer than P75 for phase_4
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 16, 2005
CompletedFirst Posted
Study publicly available on registry
August 18, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedAugust 18, 2005
August 1, 2005
August 16, 2005
August 17, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy response rate
Secondary Outcomes (4)
Time to progression
Time to treatment failure
Toxicity
Incidence and severity of adverse events
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- East Valley Hematology and Oncology Medical Grouplead
- Mena, Raul, M.D.collaborator
- Pharmatech Oncologycollaborator
- Astex Pharmaceuticals, Inc.collaborator
Study Sites (52)
Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, 35661, United States
East Valley Hematology and Oncology Medical Group
Burbank, California, 91505, United States
Bay Area Cancer Research Group
Concord, California, 94520, United States
Lalita Pandit, MD, Inc.
Fountain Valley, California, 92708, United States
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, 92708, United States
Robert A. Moss, M.D. FACP, Inc.
Fountain Valley, California, 92708, United States
Metropolitan Hematology Oncology Medical Group
Los Angeles, California, 90057, United States
North County Oncology
Oceanside, California, 92056, United States
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030, United States
Cancer and Blood Institute Medical Group
Rancho Mirage, California, 92270, United States
St. Teresa Comprehensive Cancer Center
Stockton, California, 95207, United States
Medical Group of North County
Vista, California, 92081, United States
The Oncology Clinic, PC
Colorado Springs, Colorado, 80907, United States
Mile High Oncology
Denver, Colorado, 80210, United States
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, 33435, United States
Integrated Community Oncology Network
Jacksonville, Florida, 32256, United States
Osceola Cancer Center
Kissimmee, Florida, 34741, United States
Pasco Hernando Oncology Associates, PA
New Port Richey, Florida, 34642, United States
Pasco Pinellas Cancer Center
New Port Richey, Florida, 34652, United States
Augusta Oncology Associates, PC
Augusta, Georgia, 30901, United States
Spalding Oncology Services
Griffin, Georgia, 30224, United States
St Luke's Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Oncology Hematology Assoc. of Northern Illinois
Gurnee, Illinois, 60031, United States
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, 46202, United States
Arnett Cancer Care
Lafayette, Indiana, 47904, United States
Cancer Care Center
New Albany, Indiana, 47150, United States
Kentucky Cancer Clinic
Hazard, Kentucky, 41701, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Chesapeake Oncology Hematology Associates
Baltimore, Maryland, 21225, United States
Auerbach Hematology Oncology Associates, Inc.
Baltimore, Maryland, 21237, United States
Genesee Cancer & Blood Disease Treatment Center, PC
Flint, Michigan, 48503, United States
West Michigan Regional Cancer & Blood Center
Free Soil, Michigan, 49411, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503, United States
Branson Oncology Clinic
Branson, Missouri, 65616, United States
St. Louis Hematology Oncology Specialists, Inc.
St Louis, Missouri, 63117, United States
Sierra Nevada Oncology Care
Carson City, Nevada, 89703, United States
Nevada Cancer Center
Las Vegas, Nevada, 89109, United States
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003, United States
Ellioth Fishkin, MD
Elizabeth, New Jersey, 07201, United States
Westchester Hematology Oncology Associates
Mount Kisco, New York, 10549, United States
Mid Dakota Clinic/Odyssey Research
Bismarck, North Dakota, 58501, United States
Summa Health System Hospitals
Akron, Ohio, 44304, United States
Nashat Y. Gabrail, MD, Inc.
Canton, Ohio, 44718, United States
Sambandam and Joseph Associates, Inc
Cranston, Rhode Island, 02920, United States
Charleston Hematology Oncology, PA
Charleston, South Carolina, 29403, United States
South Carolina Oncology Associates
Columbia, South Carolina, 29210, United States
The Family Cancer Center
Collierville, Tennessee, 38017, United States
C. Michael Jones, MD, PC
Germantown, Tennessee, 38138, United States
JPS Center for Cancer Care
Fort Worth, Texas, 76104, United States
Cache Valley Cancer Treatment & Research Clinic, Inc.
Logan, Utah, 84341, United States
Cancer Outreach Associates, PC
Abingdon, Virginia, 24211, United States
Virginia Oncology Care, PC
Richlands, Virginia, 24641, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raul Mena, MD
East Valley Hematology and Oncology Group
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 16, 2005
First Posted
August 18, 2005
Study Start
January 1, 2003
Study Completion
April 1, 2009
Last Updated
August 18, 2005
Record last verified: 2005-08