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Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00051701
Recruitment Status : Terminated
First Posted : January 17, 2003
Last Update Posted : March 5, 2015
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:
The purpose of this study is to determine the optimal dose of Campath for patients with relapsing or refractory (failed standard therapy) non-Hodgkin's lymphoma. The study will also evaluate the safety of the drug and whether it is effective in treating these patients.

Condition or disease Intervention/treatment Phase
Non-Hodgkins Lymphoma Drug: alemtuzumab Phase 1 Phase 2

Detailed Description:
This study is being conducted in 2 parts with the primary objective of part 1 being to determine the maximum tolerated dose (MTD) of CAMPATH (alemtuzumab, MABCAMPATH, CAMPATH) administered intravenously (IV) once a week as treatment for relapsing or refractory non-Hodgkin's lymphoma (NHL). The primary objective of part 2 is to determine the overall response rate (complete response, CR/unconfirmed , plus partial response) of weekly IV CAMPATH in the treatment of relapsing or refractory NHL. This is a Phase I/II study, open-label, multicenter study to evaluate the efficacy and safety of weekly IV CAMPATH as therapy for patients with relapsing or refractory non-Hodgkin's lymphoma.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma
Study Start Date : December 2002
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Alemtuzumab

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patients must have:

  • Pathologically confirmed diagnosis of relapsing or refractory non-Hodgkin's lymphoma that has failed conventional therapy.
  • 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: Patients must not have:

  • Prior autologous bone marrow or stem cell transplant within 6 months of study entry.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051701


Locations
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United States, Colorado
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
Kansas City, Missouri, United States
United States, New Mexico
Santa Fe, New Mexico, United States
United States, Ohio
Dayton, Ohio, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Texas
Dallas, Texas, United States
Ft. Worth, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
United States, Washington
Spokane, Washington, United States
Vancouver, Washington, United States
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Medical Monitor Genzyme, a Sanofi Company
More Information
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Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00051701    
Other Study ID Numbers: CAM.NHL232
BLA 99-0786
First Posted: January 17, 2003    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015
Keywords provided by Sanofi:
Non-Hodgkins lymphoma
NHL
Campath
alemtuzumab
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Alemtuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents