Clinical trial · Interventional
Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma
A Phase I Trial of Vaccination With Lethally Irradiated Lymphoma Cells Admixed With Granulocyte-Macrophage Colony Stimulating Factor Secreting K562 Cells for the Treatment of Previously Untreated or Relapses Follicular 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)
The purpose of this study is to compare the safety and immune activity of three doses of tumor vaccine. In recent years, researchers at the Dana-Farber Cancer Institute have discovered that vaccines made from patient's own cancer cell, that have been engineered in the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer. GM-CSF is a naturally occuring hormone in the body that helps our immune system fight infections and diseases. One of the goals of this study is to determine whether these vaccinations will improve the immune system's ability to recognize and destroy the participant's lymphoma cells.
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 |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biological/Vaccine
- description
- Biological/Vaccine: Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells Dose will vary depending upon number of cells collected and when the participant is enrolled on the study: the vaccine is given as an injection under the skin once weekly for 3 weeks then every other week for 3 vaccines. \--------------------------------------------------------------------------------
- interventionNames
- Biological: Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells
Primary outcomes (1)
- measure
- To determine the safety and toxicity of administering vaccine composed of lethally irradiated lymphoma cells admixed with GM-CSF secreting K562 cells in patients with follicular lymphoma.
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- To describe the biologic activity of the study vaccine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed follicular lymphoma * Patients with relapsed follicular lymphoma achieving at least a PR following their most recent systemic chemotherapy and/or immunotherapy regimen. * Lymphoma accessible for sampling or existing cryopreserved lymphoma tumor judged suitable for vaccine preparation. * 4 weeks must have elapsed between the completion of the the last chemotherapy, immunotherapy, glucocorticoid therapy, radiotherapy, or experimental therapy. * ECOG Performance Status 0 or 1 * Estimated life expectancy of \> 6 months * 35 years of age or older * Adequate recovery of drug related toxicities, surgery or radiation therapy * Greater than 6 months since autologous stem cell transplantation * Laboratory parameters as outlined in the protocol Exclusion Criteria: * Uncontrolled active infection or illness * Psychiatric illness/social situation that would limit study compliance * Pregnancy or nursing mothers * Evidence of infection with HIV or viral hepatitis * Other invasive malignancy * Existing autoimmune cytopenia * Previous allogeneic stem cell transplant * Pre-existing autoimmune disease requiring anti-inflammatory therapy * Participation in previous vaccine trial * Any component of grade 3 follicular lymphoma or transformed follicular lymphoma
References
Publications (1)
- DERIVEDJacobsen E, Plant A, Redd R, Armand P, McDonough M, Ihuoma U, Fisher DC, LaCasce A, Ritz J, Dranoff G, Freedman A. A phase I trial of vaccination with lethally irradiated lymphoma cells admixed with granulocyte-macrophage colony-stimulating factor secreting K562 cells for the treatment of follicular lymphoma. Leuk Lymphoma. 2024 Dec;65(12):1864-1874. doi: 10.1080/10428194.2024.2381651. Epub 2024 Jul 21. PMID 39034493