Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma
BiovaxID
Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission
1 other identifier
interventional
629
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2000
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 15, 2004
CompletedFirst Posted
Study publicly available on registry
September 17, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 3, 2012
February 1, 2012
12.9 years
September 15, 2004
February 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Study Arms (2)
ID-KLH + GM-CSF
EXPERIMENTALKLH + GM-CSF
ACTIVE COMPARATORInterventions
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
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
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Hsu FJ, Caspar CB, Czerwinski D, Kwak LW, Liles TM, Syrengelas A, Taidi-Laskowski B, Levy R. Tumor-specific idiotype vaccines in the treatment of patients with B-cell lymphoma--long-term results of a clinical trial. Blood. 1997 May 1;89(9):3129-35.
PMID: 9129015BACKGROUNDBendandi M, Gocke CD, Kobrin CB, Benko FA, Sternas LA, Pennington R, Watson TM, Reynolds CW, Gause BL, Duffey PL, Jaffe ES, Creekmore SP, Longo DL, Kwak LW. Complete molecular remissions induced by patient-specific vaccination plus granulocyte-monocyte colony-stimulating factor against lymphoma. Nat Med. 1999 Oct;5(10):1171-7. doi: 10.1038/13928.
PMID: 10502821BACKGROUNDKwak LW, Campbell MJ, Czerwinski DK, Hart S, Miller RA, Levy R. Induction of immune responses in patients with B-cell lymphoma against the surface-immunoglobulin idiotype expressed by their tumors. N Engl J Med. 1992 Oct 22;327(17):1209-15. doi: 10.1056/NEJM199210223271705.
PMID: 1406793BACKGROUNDDar MM, Kwak LW. Vaccination strategies for lymphomas. Curr Oncol Rep. 2003 Sep;5(5):380-6. doi: 10.1007/s11912-003-0022-x.
PMID: 12895388BACKGROUNDSchuster SJ, Neelapu SS, Gause BL, Janik JE, Muggia FM, Gockerman JP, Winter JN, Flowers CR, Nikcevich DA, Sotomayor EM, McGaughey DS, Jaffe ES, Chong EA, Reynolds CW, Berry DA, Santos CF, Popa MA, McCord AM, Kwak LW. Vaccination with patient-specific tumor-derived antigen in first remission improves disease-free survival in follicular lymphoma. J Clin Oncol. 2011 Jul 10;29(20):2787-94. doi: 10.1200/JCO.2010.33.3005. Epub 2011 May 31.
PMID: 21632504RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carlos F Santos, PhD
Biovest International
- PRINCIPAL INVESTIGATOR
Stephen J Schuster, MD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2004
First Posted
September 17, 2004
Study Start
January 1, 2000
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
February 3, 2012
Record last verified: 2012-02