- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00046683
Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Lymphocytic Leukemia
July 27, 2016 updated by: Genzyme, a Sanofi Company
A Phase III Study to Evaluate the Efficacy and Safety of Front-Line Therapy With Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Chronic Lymphocytic Leukemia
This is a Phase III, open-label, multicenter, randomized, comparative study of Campath versus chlorambucil as front line therapy in patients with progressive B-Cell Lymphocytic Leukemia (B-CLL).
Eligible patients must have previously untreated, Rai stage I-IV disease, and be experiencing progression of their B-CLL requiring treatment.
Patients who meet all eligibility criteria may be randomized on a 1:1 basis to receive either Campath or chlorambucil.
An estimated 284 patients (142 per treatment arm) from approximately 40 or more investigational sites will be randomized to one of the two treatment arms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
284
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States
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Arkansas
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Little Rock, Arkansas, United States
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Florida
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Ft. Myers, Florida, United States
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Tampa, Florida, United States
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Illinois
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Hines, Illinois, United States
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Kentucky
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Louisville, Kentucky, United States
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Paducah, Kentucky, United States
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Louisiana
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Lafayette, Louisiana, United States
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Mississippi
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Jackson, Mississippi, United States
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Tupelo, Mississippi, United States
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Missouri
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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Montana
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Billings, Montana, United States
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Nebraska
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Omaha, Nebraska, United States
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New York
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New Hyde Park, New York, United States
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Rochester, New York, United States
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North Carolina
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Durham, North Carolina, United States
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South Dakota
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Sioux Falls, South Dakota, United States
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Texas
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San Antonio, Texas, United States
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Virginia
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Norfolk, Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histopathologically confirmed diagnosis of B-CLL with CD5, CD19, or CD23 positive clone.
- Rai Stage I through IV disease with evidence of progression as evidenced by the presence of one or more of the following:1. Disease-related B symptoms (fever of greater than 38 celsius (100.5 F) for greater than or equal to 2 weeks without evidence of infection, night sweats without evidence of infection, weight loss >10% within previous 6 months. 2. Evidence of progression marrow failure as manifested by: a. decrease in hemoglobin to <11g/dL or b. decrease in platelet count to <100x10 to the ninth/L within the previous 6 months or c. decrease in absolute neutrophil count (ANC) to <1.0x10 to the ninth/L within the previous 6 months. 3. Progressive splenomegaly to >2 cm below the left costal margin or other organomegaly with progressive increase over 2 consecutive clinic visits greater than or equal to 2 weeks apart. 4. Progressive lymphadenopathy with at least 5 sites of involvement with either two nodes at least 2cm in longest diameter or one node greater than or equal to 5cm in longest diameter with progressive increase over 2 consecutive visits greater than or equal to weeks apart. 5. Progressive lymphocytes with an increase of >50% over a 2-month period, or an anticipated doubling time of less than 6 months.
- Received no previous chemotherapy for B-CLL.
- Life expectancy of at least 12 weeks.
- WHO performance status of 0, 1, or 2.
- Serum creatinine less or equal to 2.0 times the institutional upper limit of normal (ULN) value.
- Adequate liver function as indicated by a total bilirubin, AST, and ALT less or equal to 2 times the institutional ULN value, unless directly attributable to the disease.
- Female patients with childbearing potential must have a negative serum pregnancy test within 2 weeks prior to randomization. Male and female patients must agree to use an effective contraceptive method while on study treatment, if appropriate, and for a minimum of 6 months after study therapy.
- Signed, written informed consent.
- 18 years of age or older.
Exclusion Criteria:
- ANC less than 500 million per liter or platelet count less than 10 billion per liter.
- Medical condition requiring chronic use of oral corticosteroids.
- Autoimmune thrombocytopenia.
- Previous bone marrow transplant.
- Use of investigational agents within previous 30 days.
- Positive for HIV.
- Past history of anaphylaxis following exposure to rat or mouse-derived complementary determining region (CDR) grafted humanized monoclonal antibodies.
- Active infection.
- Serious cardiac or pulmonary disease that could interfere with their ability to participate in the study.
- Recent documented (with in 2 years) of active tuberculosis (TB), current active TB, or currently receiving anti-tuberculosis medication.
- Active secondary malignancy.
- Central nervous system involvement with CLL.
- Positive quantitative CMV by PCR assay (using the laboratory normal ranges).
- A diagnosis of mantle cell lymphoma.
- Other severe, concurrent diseases or mental disorders.
- Pregnant or lactating women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Campath vs. chlorambucil
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Secondary Outcome Measures
Outcome Measure |
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survival comparison
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2001
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
October 1, 2002
First Submitted That Met QC Criteria
October 1, 2002
First Posted (Estimate)
October 2, 2002
Study Record Updates
Last Update Posted (Estimate)
July 28, 2016
Last Update Submitted That Met QC Criteria
July 27, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAM307
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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