Personalized Active Immunotherapy (Vaccine Therapy) and Sargramostim Given After Standard of Care Treatment With Rituximab and Chemotherapy for Initial Treatment With Lymphoma
A Phase 2 Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With Follicular Non-Hodgkin's Lymphoma (fNHL) Following Primary Treatment With Rituximab and Chemotherapy (R-Chemo)
1 other identifier
interventional
N/A
1 country
9
Brief Summary
The treatment being investigated is a patient- and tumor-specific therapy known as a personalized active immunotherapy. Personalized active immunotherapy is an attempt to use a person's own immune system to combat disease. Sargramostim (a.k.a. GM-CSF) is given together with the personalized active immunotherapy because it may increase the immune system's response and, therefore, aid in the effect of the personalized active immunotherapy. This approach has previously been studied in patients with follicular Non-Hodgkin's lymphoma and other B-cell malignancies. Encouraging efficacy results and a favorable safety profile have been seen to date in these studies.
Trial Health
Trial Health Score
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9 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 31, 2007
CompletedFirst Posted
Study publicly available on registry
August 2, 2007
CompletedMarch 18, 2008
March 1, 2008
July 31, 2007
March 14, 2008
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- Previously untreated follicular NHL
- Stage III or IV disease requiring treatment
- Able to receive rituximab and chemotherapy (rituximab with cyclophosphamide, vincristine, and prednisone either with or without doxorubicin)
- Able to provide tumor sample adequate for Id-KLH manufacture
- ≥ 18 years of age
- At least one bi-dimensionally measurable lesion ≥ 2 cm by CT scan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Keck School of Medicine of University Southern California
Los Angeles, California, 90089, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680, United States
Weill Medical College of Cornell University, NY Presbyterian Hospital
New York, New York, 10021, United States
Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73174, United States
Providence Portland Cancer Center
Portland, Oregon, 97213, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 31, 2007
First Posted
August 2, 2007
Study Start
May 1, 2007
Last Updated
March 18, 2008
Record last verified: 2008-03