Clinical trial · Interventional
Vaccine Therapy With or Without Cryosurgery in Treating Patients With Residual, Relapsed, or Refractory B-Cell Non-Hodgkin Lymphoma
LS1081, "A Pilot Study of Dendritic Cell Therapy Delivered Intratumorally After Cryoablation or Intradermally for Patients With B-Cell Non-Hodgkin's 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: Vaccines, such as dendritic cell therapy (DC) made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells by freezing them. Giving vaccine therapy together with cryosurgery may kill more tumor cells. PURPOSE: This clinical trial studies giving vaccine therapy together with or without cryosurgery in treating patients with B-cell Non-Hodgkin's lymphoma.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Diffuse Mixed Cell Lymphoma | — | UNRESOLVED | — |
| Adult Diffuse Small Cleaved Cell Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.85 |
| Adult Grade III Lymphomatoid Granulomatosis | Adult Grade III Lymphomatoid Granulomatosis | ONTOLOGY_EXACT | 0.98 |
| Adult Immunoblastic Large Cell Lymphoma | Adult Immunoblastic Lymphoma | ALIAS | 0.90 |
| Adult Lymphoblastic Lymphoma | Adult Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Cutaneous B-cell Non-Hodgkin Lymphoma | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous dendritic cell-tumor fusion vaccine | Biological | — | UNRESOLVED |
| cryotherapy | Procedure | — | UNRESOLVED |
| dendritic cell vaccine therapy | Biological | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pneumococcal polyvalent vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Patients receive pneumococcal polyvalent vaccine intramuscularly in weeks -4, 2, and 10. Patients undergo cryoablation followed by dendritic cell vaccine (CA-DC) intratumorally in weeks 0, 2, 4, 6, 10, 14, 18, and 22.
- interventionNames
- Biological: dendritic cell vaccine therapy
- Procedure: cryotherapy
- Biological: pneumococcal polyvalent vaccine
- Other: laboratory biomarker analysis
- Other: immunoenzyme technique
- Other: immunohistochemistry staining method
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Patients receive pneumococcal polyvalent vaccine as in arm A. Patients also receive autologous dendritic cell-tumor fusion vaccine (TL-DC) intradermally in weeks 0, 2, 4, 6, 10, 14, 18, and 22.
- interventionNames
- Biological: dendritic cell vaccine therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmation of biopsy-proven B-cell non-Hodgkin's lymphoma, excluding chronic lymphocytic leukemia, primary CNS lymphoma and Burkitt's lymphoma. * Patient must have at least 2 measurable lesions that are \>= 1.5cm in one dimension. One of the lesions, must meet additional criteria a or b depending on the treatment arm. a) For Arm A, patient must have at least one lesion that is \>= 2.0cm and is amenable to image-guided cryoablation and multiple vaccine injections as determined by Interventional Radiology (including tumors that can be safely accessed using imaging guidance and treated with minimal risk to adjacent structures). b) For Arm B, patient must have one lesion that can be excised for in vitro vaccine preparation. * ECOG Performance Status (PS) 0, 1, 2 * Absolute neutrophil count \> 1000/uL * Absolute lymphocyte count \> 500/uL * PLT \>= 100,000/uL * HgB \>= 8.0 g/dL * Total bilirubin =\< 1.5 x upper limit of normal (ULN) or if total bilirubin is \> 1.5 x ULN, the direct bilirubin must be normal * Negative serum pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only * Provide informed written consent * Willingness to return to a Lymphoma SPORE enrolling institution for follow-up * Patient willing to provide tissue and blood samples for research purposes Exclusion Criteria: * Pregnant women * Nursing women * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Patients known to be HIV positive * Serious non-malignant disease such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations or other conditions which in the opinion of the investigator would compromise protocol objectives * Receiving any other investigational agent considered as a treatment for the primary neoplasm * History of other primary malignancy requiring systemic treatment within 6 months of protocol enrollment * Patients must not have another active malignancy requiring treatment * Patients must not be receiving chemotherapy or immunotherapy for another cancer * Prior allogeneic bone marrow or peripheral blood stem cell transplantation * Prior autologous bone marrow or peripheral blood stem cell support within 1 year * Major surgery other than diagnostic surgery =\< 4 weeks * History of hypersensitivity and anaphylactoid reactions to pneumococcal vaccine or any component of the formulation, including diphtheria toxoid * Active autoimmune disease such as Crohn's disease, rheumatoid arthritis, Sjogrens' disease, systemic lupus erythematosis, or similar conditions * Coagulopathy, including the use of Coumadin or heparin anticoagulants that cannot be discontinued for the cryoablation procedure (NOTE: Heparin for line patency without detectable lab abnormalities for coagulation will be allowed) * Patients must be off corticosteroids for at least 2 weeks prior to registration (this includes oral, IV, subcutaneous, or inhaled route of administration); patients on chronic corticosteroid for adrenal insufficiency or other reasons may enroll if they receive less than 10 mg/day of prednisone (or equivalent) * Patients with active CNS malignancy are not eligible for this trial
References
Publications (0)
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