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

This study has been terminated.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00051701
First received: January 15, 2003
Last updated: July 28, 2009
Last verified: December 2005
  Purpose

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 Intervention Phase
Non-Hodgkins Lymphoma
Drug: alemtuzumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Estimated Enrollment: 61
Study Start Date: December 2002
Estimated Study Completion Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051701

Locations
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
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00051701     History of Changes
Other Study ID Numbers: CAM.NHL232, BLA 99-0786
Study First Received: January 15, 2003
Last Updated: July 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
Non-Hodgkins lymphoma
NHL
Campath
alemtuzumab

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Alemtuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014