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NCT03035331 · ClinicalTrials.gov registry record · Phase 1
Dendritic Cell Therapy, Cryosurgery, and Pembrolizumab in Treating Patients With Non-Hodgkin Lymphoma
A Phase 1 study of Small Lymphocytic Lymphoma and Recurrent Diffuse Large B-Cell Lymphoma, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT03035331: Completed Phase 1 study of Small Lymphocytic Lymphoma and Recurrent Diffuse Large B-Cell Lymphoma, sponsored by Mayo Clinic.
NCT03035331 is a Phase 1 study of Small Lymphocytic Lymphoma and Recurrent Diffuse Large B-Cell Lymphoma that has completed, run by Mayo Clinic. The registered enrollment target is 11 participants, below the 193-participant average among 81 other Small Lymphocytic Lymphoma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03035331, a Phase 1 study of Small Lymphocytic Lymphoma and Recurrent Diffuse Large B-Cell Lymphoma, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the best dose and side effects of dendritic cell therapy, cryosurgery and pembrolizumab in treating patients with non-Hodgkin lymphoma. Vaccines, such as dendritic cell therapy 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving dendritic cell therapy, cryosurgery and pembrolizumab may work better at treating non-Hodgkin lymphoma.
Primary Outcome
Maximum tolerated dose (MTD) will be defined as the dose level that does not induce dose limiting toxicity in at least one-third of patients. DLTs are defined as Grade 4 or 5 ANC or PLT for at least 7 days, grade 3 plus Infections and infestations, febrile neutropenia defined as fever ≥38.5oC (38 \>1 hour) with grade 4 plus neutropenia, at least Grade 3 erythema multiforme, ulceration, or urticaria that does not resolve to Grade 2 or less within \> three weeks, at least grade 3 bronchial obstruc
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Cryosurgery
- BIOLOGICAL Pneumococcal 13-valent Conjugate Vaccine
- BIOLOGICAL Dendritic Cell Therapy
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-08-15 |
| Est. Completion | 2022-09-10 |
| Phase | Phase 1 |
What the finished NCT03035331 record still lists
NCT03035331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 193-participant average among 81 other Small Lymphocytic Lymphoma trials with a reported enrollment target (94% lower).
The record links to 10 conditions, with Small Lymphocytic Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03035331 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03035331 about?
NCT03035331 is a clinical study titled "Dendritic Cell Therapy, Cryosurgery, and Pembrolizumab in Treating Patients With Non-Hodgkin Lymphoma". This phase I/II trial studies the best dose and side effects of dendritic cell therapy, cryosurgery and pembrolizumab in treating patients with non-Hodgkin lymphoma. Vaccines, such as dendritic cell therapy made from a person's tumor cells and white blood cells may help the body build an effective i...
What is the current status of trial NCT03035331?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2017-08-15. Estimated completion is 2022-09-10.
What conditions does trial NCT03035331 study?
This clinical trial studies the following conditions: Small Lymphocytic Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Follicular Lymphoma, Recurrent Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT03035331?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Cryosurgery (PROCEDURE), Pneumococcal 13-valent Conjugate Vaccine (BIOLOGICAL), Dendritic Cell Therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT03035331?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03035331 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03035331's enrollment target sits among peer trials
11 80th of 81 higher than 2 of 81 other Small Lymphocytic Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small Lymphocytic Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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