Non-Hodgkins Lymphoma
Conditions
Keywords
follicular, lymphoma, Non-Hodgkins, idiotype, vaccine, indolent follicular Non-Hodgkins Lymphoma, tumor-derived, B-cell, cancer
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.
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.
Interventions
BIOLOGICALFNHLId1
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
BIOLOGICALKLH + 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
Sponsors
Biovest International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission) in idiotype vaccine treated patients | until date of relapse |
Secondary
| Measure | Time frame |
|---|---|
| To determine the ability of the idiotype vaccine to produce a molecular complete remission | once subject achieves molecular CR |
| To determine the impact of molecular disease free survival | until relapse |
| To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor | varies |
| To compare the overall survival of subjects randomized to receive either treatment | minimum 5 years from last subject randomized |
| To confirm the safety of 5 monthly injections of the vaccine with GM-CSF | 4 days |
Outcome results
None listed