Status:
UNKNOWN
Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma
Lead Sponsor:
Biovest International
Conditions:
Non-Hodgkins Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 pr...
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 prod...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
629 Patients enrolled
Trial Details
Trial ID
NCT00091676
Start Date
January 1 2000
End Date
December 1 2012
Last Update
February 3 2012
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