Clinical trial · Interventional
Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Stage III or Stage IV Non-Hodgkin's Lymphoma
A Phase II Trial to Evaluate the Rate of Immune Response Using Idiotype Immunotherapies Produced by Molecular Biological Means for Treatment of 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill tumor cells. Sargramostim may stimulate a person's immune system and help to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus sargramostim following chemotherapy in treating patients who have stage III or stage IV 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 |
|---|---|---|---|
| keyhole limpet hemocyanin | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| tumor cell-based vaccine therapy | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed stage III or IV, indolent non-Hodgkin's lymphoma * Follicular small cleaved cell * Follicular mixed small cleaved and large cell with less than 50% large cells * Tumor sample safely accessible by biopsy, needle aspiration, or phlebotomy * Must have adequate circulating lymphoma cells * Over 18 years old * Karnofsky 80-100% * WBC greater than 2,500/mm3 * Platelet count greater than 100,000/mm3 * Hemoglobin at least 10 g/dL * Bilirubin less than 2 mg/dL * SGOT/SGPT less than 2 times normal * Creatinine less than 2 mg/dL * HIV negative * At least 2 months since prior non-physiologic doses of prednisone of greater than 20 mg or equivalent Exclusion Criteria: * No intermediate, high grade, or other non-Hodgkin's lymphomas (e.g., mantle cell, monocytoid B cell, marginal zone, small lymphocytic, chronic lymphocytic leukemia, or follicular large cell) * No CNS metastasis * No other illness or condition, including innate or pharmacologic immunosuppression, that would preclude study * No other malignancy within the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix * Not pregnant or nursing * No prior biologic therapy for lymphoma * No prior cytotoxic therapy for lymphoma * No prior steroids for lymphoma * No concurrent maintenance steroids or greater than 5 mg of daily prednisone or equivalent * No prior radiotherapy for lymphoma A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
References
Publications (0)
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