Clinical trial · Interventional
Idiotype Vaccine for Low-Grade Non-Hodgkin's Lymphoma
Phase II Study of FavId (Tumor-Specific Idiotype-KLH) and Soluble GM-CSF Immunotherapy in Patients With Stable or Progressive Grade 1 and 2 Follicular B-Cell Lymphomas
NCT00036426CI-TRIAL-00000023unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to determine if an idiotype vaccine, made from a patient's lymphoma that has returned after chemotherapy and/or rituximab, would be able to shrink their tumor.
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 |
|---|---|---|---|
| Lymphoma, Low-Grade | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FavId (Id-KLH) active immunotherapy | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * 18 years of age * Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification) * Patients that have responded with at least stable disease to their most recent chemo- or anti-CD20 antibody (Rituxan®, Zevalin, Bexxar) therapy for a minimum of 90 days and who currently have relapsed or who continue to have stable disease. * Tumor accessible for biopsy or previously existing biopsy material * At least 1 additional bidimensional lesion measuring at least 2 cm in each dimension * Performance status (ECOG) of 0, 1 or 2 * Absolute Granulocyte count ? 1,000/mm3 * Total Bilirubin \< 2 mg/dL * AST and ALT \< 2x Upper Limit of Normal * Creatinine \< 1.5 mg/dL Exclusion Criteria * Patients who have had more than 3 prior chemotherapy or anti-CD20 regimens * Prior fludarabine * Prior tumor-specific idiotype immunotherapy * Patients whose disease has progressed within the first 90 days of their last chemotherapy or anti-CD20 treatment * Concurrent immunosuppressive therapy (high-dose steroids; etc) * Prior splenectomy * Surgery, cancer radiotherapy, steroid therapy, immunotherapy or chemotherapy within 90 days prior to first scheduled vaccination * Known history of CNS lymphoma or meningeal lymphomatosis * HIV positive * Serious non-malignant disease (e.g., psychiatric disorders, congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives * Prior malignancy (excluding nonmelanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for \> 2 years * Treatment with an investigational drug within 30 days prior to study entry * Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with FavId.
References
Publications (0)
Data not yet available
No reference posted for this study.