18 and older, any sex, with Aggressive Non-Hodgkin Lymphoma or Indolent Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients That Experienced a Dose Limiting Toxicity (DLT)Primary· 56 days
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 obstruction, pneumonitis, or wheezing at least grade 3 allergic reaction or autoimmunity at least grade 3 t
Group
Value
95% CI
Phase 1 Dose Level 1
0
Percentage of Complete Responses of Combination Therapy With Pembrolizumab, Cryoablation, and Intra-tumor Injection of Autologous Dendritic Cells (DC) at Maximum Tolerated Dose (MTD) DosePrimary· 24 months
The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated.
Group
Value
95% CI
Phase 1 Dose Level 1
0
Phase 2 Dose Level 1
0
Progression Free SurvivalSecondary· 24 months
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Group
Value
95% CI
Phase 1 Dose Level 1
5
3.8 – NA
Phase 2 Dose Level 1
3.6
2.9 – NA
Treatment Free SurvivalSecondary· 34 months
The distribution of treatment-free survival will be estimated using the method of Kaplan-Meier.
Group
Value
95% CI
Phase 1 Dose Level 1
15.8
NA – NA
Phase 2 Dose Level 1
18.1
5.2 – NA
Duration of ResponseSecondary· 11 months
The distribution of duration of complete response will be estimated using the method of Kaplan-Meier.
Group
Value
95% CI
All Patients
6
1.4 – NA
Disease Free Survival RateSecondary· 2 years
The percentage of patients without disease at two years post start of treatment.
Group
Value
95% CI
Phase 1 Dose Level 1
0
Phase 2 Dose Level 1
0
Overall SurvivalSecondary· 5 years
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Group
Value
95% CI
Phase 1 Dose Level 1
NA
3.8 – NA
Phase 2 Dose Level 1
NA
3.6 – NA
Percentage of Patients With Grade 4 or 5 Adverse EventsSecondary· Up to 4 years
Will be assessed by Common Terminology Criteria for Adverse Events version 4.0.
Group
Value
95% CI
Phase 1 Dose Level 1
0
Phase 2 Dose Level 1
0
Percent of Patients With Improved Quality of LifeSecondary· 4 years
Will be measured using the Functional Assessment of Cancer Therapy-lymphoma. The assessment will be scored according to the scoring algorithm. Changes from baseline will be calculated at each assessment time points. Mean change scores at each time point will be calculated to determine if quality of life is reduced over the course of treatment. Longitudinal techniques will be employed to describe changes over time.
Group
Value
95% CI
Phase 1 Dose Level 1
33.3
Phase 2 Dose Level 1
57.14
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events time frame was 4 years, mortality time frame was 5 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06593106 — Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial
· NA
· recruiting
NCT04429204 — Cryoablation for the Promotion of Local Tumor Infiltration in Patients With Mesothelioma
· NA
· withdrawn
NCT04693377 — Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME T
· NA
· recruiting
NCT04249167 — Cryoablation, Atezolizumab/Nab-paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
· EARLY_PHASE1
· withdrawn
NCT04150939 — Cryoablation for the Treatment of Metastatic Cancer
· NA
· active not recruiting
Other recruiting trials for Aggressive Non-Hodgkin Lymphoma
Currently open trials in the same condition.
NCT05260957 — CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma
· Phase 2
· recruiting
NCT04231877 — Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive La
· Phase 1
· recruiting
NCT03749018 — Nivolumab With DA-REPOCH Chemotherapy Regimen in Treating Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma
· Phase 2
· active not recruiting
NCT01787409 — Cholecalciferol in Improving Survival in Patients With Newly Diagnosed Cancer With Vitamin D Insufficiency
· NA
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 16 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03035331.