Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma
NCT ID: NCT00051701
Last Updated: 2015-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
61 participants
INTERVENTIONAL
2002-12-31
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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alemtuzumab
Eligibility Criteria
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Inclusion Criteria
* Measurable disease (lesions that can be accurately measured by CT scan and a greatest transverse diameter larger or equal to 1 cm or palpable lesions that both diameters larger or equal to 2 cm).
* Life expectancy of at least 12 weeks. - World Health Organization (WHO) performance status (PS) of 0, 1, or 2.
* Adequate marrow and organ function (details are listed in the protocol).
* Female patients with childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. 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 following study therapy.
* Signed, written informed consent.
Exclusion Criteria
* A history of prior allogeneic bone marrow transplant or organ transplant.
* Previously untreated non-Hodgkin's lymphoma.
* Previously treated with CAMPATH.
* Patients with bulky disease, ie any single mass \> 7.5cm.
* Prior radiotherapy to the only site of measurable disease.
* Medical condition requiring chronic use of oral, high-dose corticosteroids.
* Autoimmune thrombocytopenia.
* Use of investigational agents within previous 30 days or any anti-cancer therapy within the previous 3 weeks. Patients must have recovered from all acute toxicities of any prior therapy.
* Past history of anaphylaxis following exposure to humanized monoclonal antibodies.
* Active, uncontrolled infection, including human immunodeficiency virus (HIV) positive.
* Active secondary malignancy.
* Active central nervous system (CNS) involvement with NHL.
* Pregnant or lactating women. Male or female patients who do not agree to use effective contraceptive method(s) during the study.
* Any significant concurrent disease or illness that would, in the opinion of the investigator, compromise patient safety or compliance, or interfere with the interpretation of study results.
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Genzyme Corporation
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Indianapolis, Indiana, United States
Overland Park, Kansas, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
Santa Fe, New Mexico, United States
Dayton, Ohio, United States
Tulsa, Oklahoma, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Spokane, Washington, United States
Vancouver, Washington, United States
Countries
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Other Identifiers
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BLA 99-0786
Identifier Type: -
Identifier Source: secondary_id
CAM.NHL232
Identifier Type: -
Identifier Source: org_study_id
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