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| Sponsor: | Biovest International |
|---|---|
| Information provided by: | Biovest International |
| ClinicalTrials.gov Identifier: | NCT00091676 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkins Lymphoma |
Biological: tumor specific immune response Biological: control vaccine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission |
| Estimated Enrollment: | 629 |
| Study Start Date: | February 2000 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Biological: tumor specific immune response
5 vaccinations over a 6 month time period
|
| 2: Active Comparator |
Biological: control vaccine
5 vaccinations over a 6 month time period
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion/Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Biovest International ( Angelos Stergiou, MD/Vice President, Product Development, Medical Affairs & Clinical Research ) |
| Study ID Numbers: | BV 301 |
| Study First Received: | September 15, 2004 |
| Last Updated: | May 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00091676 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
follicular lymphoma Non-Hodgkins idiotype vaccine |
indolent follicular Non-Hodgkins Lymphoma tumor-derived B-cell cancer |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoma, Follicular Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |