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

Biovest

Status and phase: Unknown; Phase 3

Conditions: Non-Hodgkins Lymphoma

Treatments: Biological: KLH + GM-CSF; Biological: FNHLId1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00091676

BV 301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 629 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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629 participants in 2 patient groups

ID-KLH + GM-CSF

Experimental group

Treatment:

Biological: FNHLId1

KLH + GM-CSF

Active Comparator group

Treatment:

Biological: KLH + GM-CSF