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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

629 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-Hodgkins Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ID-KLH + GM-CSF

Group Type EXPERIMENTAL

FNHLId1

Intervention Type BIOLOGICAL

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

KLH + GM-CSF

Group Type ACTIVE_COMPARATOR

KLH + GM-CSF

Intervention Type BIOLOGICAL

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

Interventions

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FNHLId1

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

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No