Rituximab Plus CAMPATH in Patients With Relapsed/Refractory Low-Grade or Follicular, CD20-positive, B-cell NHL

This study has been terminated.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00077961
First received: February 13, 2004
Last updated: July 28, 2009
Last verified: December 2005
  Purpose

The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used in combination with rituximab for patients with relapsing or refractory, low-grade or follicular, CD-20-positive, B-Cell non-Hodgkin's Lymphoma. Safety will be the primary objective of phase I, while the primary objective of phase II will be to determine overall response.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: CAMPATH (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 Rituximab Plus CAMPATH in Patients With Previously Treated Relapsed or Refractory Low-Grade Follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


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

Estimated Enrollment: 49
Study Start Date: December 2003
Detailed Description:

This study is being conducted in 2 parts. Phase I will involve dose escalation of subcutaneous CAMPATH (SQ) given 3 times per week in combination with weekly doses of rituximab (375mg/m2) for a maximum of 8 weeks in order to determine the maximum tolerated dose (MTD). In Phase II patients will be treated with SQ CAMPATH at the MTD plus weekly rituximab (375mg/m2)for a maximum of 8 weeks with primary objective of defining Overall Response (OR) to this combination.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For the Phase I portion of the study, patients must have pathologically confirmed diagnosis of low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma that has relapsed or is refractory. For the Phase II portion of the study, patients must have a pathologically confirmed diagnosis of low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma (Follicular, predominantly small cleaved or follicular, mixed small cleaved and large cell, International Working Formulation classification B or C or REAL classification follicular center grade 1,2) that has relapsed or is refractory.
  • Previously treated with at least one anti-cancer regimen for NHL
  • Measurable disease (lesions that can be accurately measured in 2 dimensions by CT scan with a greatest transverse diameter of >/= to 2cm or palpable lesions with both diameters of 2cm or more)
  • Life expectancy of at least 12 weeks
  • WHO performance status or 0 or 1
  • Adequate marrow and organ function (as defined in the protocol)
  • Completed major surgery, radiotherapy, chemotherapy, immunotherapy or biotherapy/targeted therapies at least 4 weeks prior to study entry (6 weeks if treated with a nitrosourea or mitomycin). Patients must have recovered from all prior treatment toxicity to Grade 1 or less, exclusive of alopecia.

Exclusion Criteria:

  • Prior combination therapy with rituximab and CAMPATH; prior therapy with either agent alone is permitted
  • A history of a T-cell lymphoma
  • Known AIDS-related HIV-positive lymphoma
  • For the Phase II portion of the study (once MTD has been determined), bulky disease, ie, any single mass >10cm or circulating malignant cells of 25,000/uL or more
  • Prior autologous bone marrow or stem cell transplant within 6 months of study entry
  • Prior allogeneic bone marrow transplant or organ transplant
  • Prior radiotherapy to the only site of measurable disease
  • Medical condition requiring chronic use of oral, high-dose corticosteroids
  • Use of investigational agents within 30 days of study enrollment
  • Past history of anaphylaxis following exposure to humanized monoclonal antibodies
  • Known, active, infection, including HIV positive
  • Diagnosis of another malignancy within the previous five (5) years, unless the probability of recurrence of the prior malignancy is < 5%. Patients with curatively treated early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, cervical intraepithelial neoplasia (CIN), and patients with a history of malignant tumor in the past that have been disease-free for at least 5 years
  • Active central nervous system (CNS) involvement with lymphoma
  • Pregnant or nursing women
  • 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
  • Active hepatitis or a history of prior viral hepatitis B or C, or positive hepatitis B serologies without prior immunization
  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: NCT00077961

Locations
United States, Colorado
Colorado Springs, Colorado, United States, 80909
United States, Florida
Ocala, Florida, United States, 34474
United States, Illinois
Park Ridge, Illinois, United States, 60068
United States, Louisiana
Lafayette, Louisiana, United States, 70506
New Orleans, Louisiana, United States, 70115
United States, Missouri
Columbia, Missouri, United States, 65201
United States, New York
Manhasset, New York, United States, 11030
United States, North Carolina
Cary, North Carolina, United States, 27511
United States, Ohio
Canton, Ohio, United States, 44718
United States, South Carolina
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00077961     History of Changes
Other Study ID Numbers: CAM.NHL233
Study First Received: February 13, 2004
Last Updated: July 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
Non-Hodgkin's Lymphoma
NHL
CAMPATH
alemtuzumab

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

ClinicalTrials.gov processed this record on September 29, 2014