A Phase 2 interventional study of autologous tumor cell vaccine and keyhole limpet hemocyanin in Lymphoma, sponsored by University of Nebraska. Terminated at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by University of Nebraska · Phase 2, Interventional, and Treatment
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Vaccine therapy may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Patients receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
5,623 studies on the registry are indexed under Lymphoma; 823 are open to participants now.
This study's enrollment of 19 is below the median of 40 across 4,534 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.
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Minimal disease state at day 100 to 6 months post-transplantatio
Tissue sample safely accessible by biopsy, needle aspiration, or phlebotomy
o Must have adequate circulating lymphoma cells
Exclusion Criteria:
Phase II trial to study the effectiveness, safety \& toxicity of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma. Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Participants receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose.
Biological: autologous tumor cell vaccine · Biological: keyhole limpet hemocyanin · Biological: sargramostim · Procedure: adjuvant therapy
Also known as: Leukine
Number of Participants With Humoral and Cellular Immune Response
evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation
Time frame: immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression
Safety of Idiotype Vaccine
To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
Time frame: At each immunization and at study completion
Toxicity of Idiotype Vaccine
To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
Time frame: At each immunization and at study completion
Changes in Quantitative Bcl-2
To evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines.
Time frame: 1 year post transplant evaluation and then annually until disease progression
| Milestone | Vaccine Therapy |
|---|---|
| Started | 19 |
| Completed | 12 |
| Not completed | 7 |
| Withdrew: Vaccine could not be produced | 1 |
| Withdrew: Physician decision | 6 |
evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation
No measurements were reported for this outcome.
To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
No measurements were reported for this outcome.
To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
No measurements were reported for this outcome.
To evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vaccine Therapy | — | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Vaccine Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 2 |
| Age, Continuous(years) | Vaccine Therapy |
|---|---|
| Mean | 46.7 ± 10.68 |
| Sex: Female, Male(Participants) | Vaccine Therapy |
|---|---|
| Female | 10 |
| Male | 9 |
| Region of Enrollment(participants) | Vaccine Therapy |
|---|---|
| United States | 19 |
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Autologous Tumor Cell Vaccine · Keyhole limpet hemocyanin · Sargramostim