Rituximab Plus CAMPATH in Patients With Relapsed/Refractory Low-Grade or Follicular, CD20-positive, B-cell NHL
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
1 other identifier
interventional
49
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 13, 2004
CompletedFirst Posted
Study publicly available on registry
February 18, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedMarch 26, 2015
March 1, 2015
2.2 years
February 13, 2004
March 25, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
Colorado Springs, Colorado, 80909, United States
Unknown Facility
Ocala, Florida, 34474, United States
Unknown Facility
Park Ridge, Illinois, 60068, United States
Unknown Facility
Lafayette, Louisiana, 70506, United States
Unknown Facility
New Orleans, Louisiana, 70115, United States
Unknown Facility
Columbia, Missouri, 65201, United States
Unknown Facility
Manhasset, New York, 11030, United States
Unknown Facility
Cary, North Carolina, 27511, United States
Unknown Facility
Canton, Ohio, 44718, United States
Unknown Facility
Greenville, South Carolina, 29615, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 13, 2004
First Posted
February 18, 2004
Study Start
December 1, 2003
Primary Completion
February 1, 2006
Last Updated
March 26, 2015
Record last verified: 2015-03