Clinical trial · Interventional
Rituxan Plus FavId (Idiotype Vaccine) for Low-grade Non-Hodgkin's Lymphoma
Phase II Trial of Rituxan(R) Plus FavId(TM) (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma
NCT00041730CI-TRIAL-00002674unknownPhase 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 is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype.
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-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Id-KLH | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * 18 years of age or older * Patients that are treatment naive OR * Relapsed or refractory following chemotherapy OR * Relapsed following a prior response to Rituxan(R) Note: Rituxan (R) may have been given as second-line therapy following an initial response to chemotherapy or in combination with chemotherapy for initial therapy of their disease. * Tumor accessible for biopsy or previously existing recent biopsy material * Measurable disease after node biopsy * Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification) * Performance status (ECOG) of 0, 1 or 2 * Absolute Granulocyte count \> 1,000/mm3 * Platelets \> 100,000/mm3 * Total Bilirubin \<2 mg/dL * AST and ALT \<2x Upper Limit of Normal * Creatinine \< 1.5 mg/dL Exclusion Criteria * Patients who are refractory to Rituxan(R) Note: Patients who did not attain a CR or PR are considered to be refractory * More than 2 prior treatment regimens (e.g. CHOP plus Rituxan(R) is one treatment regimen; CHOP followed by Rituxan(R) at initial relapse equals two treatment regimens) * Treatment w/Fludarabine within 9 months of study entry * Patients with \> 5,000 lymphocytes * Prior tumor-specific idiotype immunotherapy using the identical idiotype (patients whose idiotype has changed are eligible for retreatment with new idiotype) * Concurrent immunosuppressive therapy (high-dose steroids; ect.) * Known history of CNS lymphoma or meningeal lymphomatosis * HIV positive * Serious non-malignant disease (e.g., psychiatric disorders, compromised pulmonary function (e.g. active asthma, COPD, pneumonitis, bronchiolitis obliterans), 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 non-melanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for \>2 years * Treatment with an investigational drug within 8 weeks prior to study entry * Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.