Rituxan Plus FavId (Idiotype Vaccine) for Low-grade Non-Hodgkin's Lymphoma
Phase II Trial of Rituxan(R) Plus FavId(TM) (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma
1 other identifier
interventional
90
1 country
15
Brief Summary
The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
15 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
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 15, 2002
CompletedFirst Posted
Study publicly available on registry
July 17, 2002
CompletedSeptember 30, 2009
October 1, 2004
July 15, 2002
September 29, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- years of age or older
- Patients that are treatment naive OR
- Relapsed or refractory following chemotherapy OR
- Relapsed following a prior response to Rituxan(R) Note: Rituxan (R) may have been given as second-line therapy following an initial response to chemotherapy or in combination with chemotherapy for initial therapy of their disease.
- Tumor accessible for biopsy or previously existing recent biopsy material
- Measurable disease after node biopsy
- Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification)
- Performance status (ECOG) of 0, 1 or 2
- Absolute Granulocyte count \> 1,000/mm3
- Platelets \> 100,000/mm3
- Total Bilirubin \<2 mg/dL
- AST and ALT \<2x Upper Limit of Normal
- Creatinine \< 1.5 mg/dL
You may not qualify if:
- Patients who are refractory to Rituxan(R) Note: Patients who did not attain a CR or PR are considered to be refractory
- More than 2 prior treatment regimens (e.g. CHOP plus Rituxan(R) is one treatment regimen; CHOP followed by Rituxan(R) at initial relapse equals two treatment regimens)
- Treatment w/Fludarabine within 9 months of study entry
- Patients with \> 5,000 lymphocytes
- Prior tumor-specific idiotype immunotherapy using the identical idiotype (patients whose idiotype has changed are eligible for retreatment with new idiotype)
- Concurrent immunosuppressive therapy (high-dose steroids; ect.)
- Known history of CNS lymphoma or meningeal lymphomatosis
- HIV positive
- Serious non-malignant disease (e.g., psychiatric disorders, compromised pulmonary function (e.g. active asthma, COPD, pneumonitis, bronchiolitis obliterans), congestive heart failure, or active uncontrolled bacterial, viral or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives
- Prior malignancy (excluding non-melanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for \>2 years
- Treatment with an investigational drug within 8 weeks prior to study entry
- Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Favrillelead
Study Sites (15)
University of California, San Diego
La Jolla, California, 92093, United States
Tower Hematology Oncology Medical Group
Los Angeles, California, 90048, United States
Oncology Associates of San Diego
San Diego, California, 92123, United States
University California, San Francisco
San Francisco, California, 94143, United States
University of Florida, Jacksonville
Jacksonville, Florida, 32209, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northwestern University
Chicago, Illinois, 60611, United States
Ochsner Clinical Foundation
New Orleans, Louisiana, 70121, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center
The Bronx, New York, 10466, United States
Oncology/Hematology Care Clinical Cancer Institute
Cincinnati, Ohio, 45219, United States
University Hospitals of Cleveland Case Western, Ireland Cancer Center
Cleveland, Ohio, 44106, United States
The Ohio State University
Columbus, Ohio, 43210, United States
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
University of Virginia
Charlottesville, Virginia, 22902, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 15, 2002
First Posted
July 17, 2002
Study Start
July 1, 2002
Last Updated
September 30, 2009
Record last verified: 2004-10