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

March 4, 2015 updated by: Genzyme, a Sanofi Company
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

61

Phase

  • Phase 2
  • Phase 1

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

  • United States
    • Colorado
      • Aurora, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Denver, Colorado, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Overland Park, Kansas, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • Kansas City, Missouri, United States
    • New Mexico
      • Santa Fe, New Mexico, United States
    • Ohio
      • Dayton, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, 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
    • Washington
      • Spokane, Washington, United States
      • Vancouver, Washington, United States

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: 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.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

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

December 1, 2002

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

January 15, 2003

First Submitted That Met QC Criteria

January 16, 2003

First Posted (Estimate)

January 17, 2003

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAM.NHL232
  • BLA 99-0786

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.

Clinical Trials on Non-Hodgkins Lymphoma

Clinical Trials on alemtuzumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe