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

February 1, 2012 updated by: Biovest International

Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

629

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ID-KLH + GM-CSF
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
Active Comparator: KLH + GM-CSF
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

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: until date of relapse
until date of relapse

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the ability of the idiotype vaccine to produce a molecular complete remission
Time Frame: once subject achieves molecular CR
once subject achieves molecular CR
To determine the impact of molecular disease free survival
Time Frame: until relapse
until relapse
To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor
Time Frame: varies
varies
To compare the overall survival of subjects randomized to receive either treatment
Time Frame: minimum 5 years from last subject randomized
minimum 5 years from last subject randomized
To confirm the safety of 5 monthly injections of the vaccine with GM-CSF
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biovest International

Investigators

  • Study Director: Carlos F Santos, PhD, Biovest International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

September 15, 2004

First Submitted That Met QC Criteria

September 16, 2004

First Posted (Estimate)

September 17, 2004

Study Record Updates

Last Update Posted (Estimate)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BV 301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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