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

NCT00091676 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 629

Last updated 2012-02-03

No results posted yet for this study

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.

Conditions

  • Non-Hodgkins Lymphoma

Interventions

BIOLOGICAL

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

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

Sponsors & Collaborators

  • Biovest International

    lead INDUSTRY

Principal Investigators

  • Carlos F Santos, PhD · Biovest International

  • Stephen J Schuster, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00091676 on ClinicalTrials.gov