Clinical trial · Interventional
Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma
Phase II Trial of Maintenance Rituximab Plus FavId® and GM-CSF Immunotherapy in Patients With Treatment-Naive Indolent B-Cell Lymphoma
- 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)
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with vaccine therapy and GM-CSF may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with vaccine therapy and GM-CSF works in treating patients with indolent B-cell non-Hodgkin's lymphoma.
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 | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous immunoglobulin idiotype-KLH conjugate vaccine | Biological | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event-free survival by Kaplan-Meier
Secondary outcomes (5)
- measure
- Overall response rate (partial and complete response) at month 6 and any time
- measure
- Time-to-progression by Kaplan-Meier
- measure
- Duration of response
- measure
- Immune response by cellular or humoral anti-idiotype response positive
- measure
- Safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed indolent B-cell non-Hodgkin's lymphoma of 1 of the following subtypes: * Grade 1 or 2 follicular lymphoma * Tumor must be accessible to biopsy or biopsy material available for preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) * Measurable or evaluable disease after node biopsy * No mantle cell, marginal zone, MALT-type, small lymphocytic, or grade 3 follicular (follicular large cell) lymphoma * No CNS involvement with lymphoma PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Platelet count \> 100,000/mm\^3 * WBC ≥ 3,000/mm\^3 Hepatic * AST and ALT ≤ 2 times upper limit of normal * Bilirubin ≤ 2 mg/dL Renal * Creatinine ≤ 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after completion of study treatment * HIV negative * No other medical or psychiatric disease that would preclude study compliance * No other malignancy (active or treated) within the past 5 years PRIOR CONCURRENT THERAPY: Radiotherapy * Prior local radiotherapy allowed Other * No other prior anticancer therapy
References
Publications (0)
Data not yet available