Clinical trial · Interventional

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

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

NCT00091676CI-TRIAL-00006185BiovaxIDunknownPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Non-Hodgkins Lymphoma	Non-Hodgkin Lymphoma	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
FNHLId1	Biological	—	UNRESOLVED
KLH + GM-CSF	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
ID-KLH + GM-CSF
interventionNames
1. Biological: FNHLId1
type
ACTIVE_COMPARATOR
label
KLH + GM-CSF
interventionNames
1. Biological: KLH + GM-CSF

Primary outcomes (1)

measure
To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission) in idiotype vaccine treated patients
timeFrame
until date of relapse

Secondary outcomes (5)

measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (5)

BACKGROUNDHsu 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 9129015
BACKGROUNDBendandi 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 10502821
BACKGROUNDKwak 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 1406793
BACKGROUNDDar MM, Kwak LW. Vaccination strategies for lymphomas. Curr Oncol Rep. 2003 Sep;5(5):380-6. doi: 10.1007/s11912-003-0022-x. PMID 12895388
RESULTSchuster 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 21632504