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| Descriptive Information Fields | |||||||||
| Brief Title † | Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma | ||||||||
| Official Title † | Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission | ||||||||
| Brief Summary | The primary objective of this Phase 3 study is to definitively confirm the safety and efficacy of BiovaxId, an autologous tumor derived immunoglobulin idiotype vaccine, as measured by a significant prolongation of the period of disease free survival when administered to patients with indolent follicular Non-Hodgkin's Lymphoma (NHL) during their first complete remission. |
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| Detailed Description | Patients with Stage III-IV follicular lymphoma and tumor > 2cm (Stage II allowed if tumor > 5cm), previously untreated by other than local radiation, provide tumor material by tissue biopsy for production of a patient-specific Ig idiotype vaccine conjugated to the immunogenic protein KLH. After completing PACE or CHOP-R chemotherapy and achieving a complete remission, followed by a waiting period to reconstitute the immune system, patients who remain in remission randomized to the active treatment arm receive a series of 5 idiotype vaccinations accompanied by the immune stimulant GM-CSF. Patients randomized to the control arm receive a time-matched series of KLH injections also accompanied by GM-CSF. Patients are subsequently studied to observe their immune responses both to the non-specific immune stimulating agents and for the specific immune response to the vaccine. Patients are followed for a minimum of 4 years post-randomization or until relapse. |
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission) in idiotype vaccine treated patients [ Time Frame: until date of relapse ] [ Designated as safety issue: Yes ] | ||||||||
| Secondary Outcome Measure † | To determine the ability of the idiotype vaccine to produce a molecular complete remission [ Time Frame: once subject achieves molecular CR ] [ Designated as safety issue: No ] To determine the impact of molecular disease free survival [ Time Frame: until relapse ] [ Designated as safety issue: No ] To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor [ Time Frame: varies ] [ Designated as safety issue: No ] To compare the overall survival of subjects randomized to receive either treatment [ Time Frame: minimum 5 years from last subject randomized ] [ Designated as safety issue: No ] To confirm the safety of 5 monthly injections of the vaccine with GM-CSF [ Time Frame: 4 days ] [ Designated as safety issue: Yes ] |
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| Condition † | Non-Hodgkins Lymphoma | ||||||||
| Intervention † | Biological: tumor specific immune response Biological: control vaccine |
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| MEDLINE PMIDs | 9129015, 10502821, 1406793, 12895388 | ||||||||
| Links | Related Info  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Active, not recruiting | ||||||||
| Enrollment † | 629 | ||||||||
| Start Date † | February 2000 | ||||||||
| Completion Date | March 2009 | ||||||||
| Eligibility Criteria † | Inclusion/Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | |||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00091676 | ||||||||
| Organization ID | BV 301 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Biovest International | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Biovest International | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | September 15, 2004 | ||||||||
| Last Updated Date | May 6, 2008 | ||||||||
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