Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma

Phase 3

• Conditions: Non-Hodgkins Lymphoma
• Interventions: Biological: FNHLId1; Biological: KLH + GM-CSF

• Registration Number: NCT00091676
• Lead Sponsor: Biovest International

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.

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2004-09-15
• Study First Submitted QC: 2004-09-16
• Study First Posted: 2004-09-17
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-03
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 629

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ID-KLH + GM-CSF	FNHLId1	-
KLH + GM-CSF	KLH + GM-CSF	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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