This trial is active, not recruiting.

Condition non-hodgkins lymphoma
Treatments fnhlid1, klh + gm-csf
Phase phase 3
Sponsor Biovest International
Start date January 2000
End date December 2012
Trial size 629 participants
Trial identifier NCT00091676, BV 301, NCT00001945, NCT00019981, NCT00096577


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
5 monthly vaccinations over a 6 month time period consisting of 0.5 mg ID-KLH s.c. on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4
(Active Comparator)
klh + gm-csf
5 monthly vaccinations at month 1, 2, 3, 4, and 6 consisting of 0.5 mg KLH s.c on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4

Primary Outcomes

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

Secondary Outcomes

To determine the ability of the idiotype vaccine to produce a molecular complete remission
time frame: once subject achieves molecular CR
To determine the impact of molecular disease free survival
time frame: until relapse
To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor
time frame: varies
To compare the overall survival of subjects randomized to receive either treatment
time frame: minimum 5 years from last subject randomized
To confirm the safety of 5 monthly injections of the vaccine with GM-CSF
time frame: 4 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion/Exclusion Criteria: - Diagnosis of indolent follicular lymphoma(follicular small-cleaved cell, follicular mixed or follicular large cell with centrocytes) with surface IgM or IgG phenotype. - Stage III-IV with lymph node > 2cm or Stage II with lymph node > 5 cm - No prior chemotherapy other than local radiation (not greater than 2 sites) - ECOG < 2 - Survival > 1 yr - Serum creatinine < 1.5 mg/dl - Bilirubin <1.5 mg/dl - SGOT/SGPT < 3.5 ULN - No HIV antibodies or HBV antigen - Negative pregnancy screen (females) - No unrelated neoplasm in the previous 10 years - No evidence of primary or secondary CNS lymphoma

Additional Information

Official title Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission
Principal investigator Stephen J Schuster, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by Biovest International.