Last reviewed · How we verify
Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting
Phase 4 trial testing Telemedicine Visit in Large B-cell Lymphoma in 25 participants. Completed in 8 December 2023.
| Lead sponsor | Vanderbilt-Ingram Cancer Center |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 25 |
| Start date | 2 December 2021 |
| Primary completion | 8 December 2023 |
| Estimated completion | 8 December 2023 |
| Sites | 1 location across United States |
Vanderbilt-Ingram Cancer Center — full company profile →
18 and older, any sex, with Large B-cell Lymphoma or Diffuse Large B-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The number of participants that received YESCARTA as outpatient therapy
| Group | Value | 95% CI |
|---|---|---|
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | 20 |
Number of subjects that were admitted to hospital at 72 hours post infusion
| Group | Value | 95% CI |
|---|---|---|
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | 2 |
Number of subjects that were admitted to the hospital at 7 days post infusion
| Group | Value | 95% CI |
|---|---|---|
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | 19 |
Number of subjects that were admitted to the hospital at 14 days post infusion
| Group | Value | 95% CI |
|---|---|---|
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | 19 |
Number of subjects that were admitted to hospital at 30 days post infusion
| Group | Value | 95% CI |
|---|---|---|
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | 19 |
Reasons as to why a participant did not receive YESCARTA in the out-patient setting
| Group | Value | 95% CI |
|---|---|---|
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | 3 | |
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | 1 | |
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | 1 |
Count of participants that had cytokine release syndrome events
| Group | Value | 95% CI |
|---|---|---|
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | 19 |
Count of participants that had an immune effector cell-associated neurotoxicity syndrome event
| Group | Value | 95% CI |
|---|---|---|
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | 8 |
Count of participants that were administered steroids during treatment
| Group | Value | 95% CI |
|---|---|---|
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | 20 |
Cost includes hospital clinic charges and CAR-T acquisition. It was pre-specified to report a single dollar amount that every participant was changed. The amount entered was the amount that each patient was charged. It was not planned to assess this amount separately for each participant.
| Group | Value | 95% CI |
|---|---|---|
| YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting | 392,237.75 |
Time frame: From initiation of protocol-indicated treatment up to approximately 12 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | YESCARTA (Axicabtagene Cil… |
|---|---|---|
| Fever | General disorders | — |
| Supraventricular tachycardia | Cardiac disorders | — |
| Encephalopathy | Nervous system disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Cytokine release syndrome | Immune system disorders | — |
| Syncope | Nervous system disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | YESCARTA (Axicabtagene Cil… |
|---|---|---|
| Fever | General disorders | — |
| Cytokine Release Syndrome | Immune system disorders | — |
| Neutrophil Count Decrease | Investigations | — |
| Fatique | General disorders | — |
| Hypotension | Vascular disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Encephalopathy | Nervous system disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| White Blood Cell Decrease | Blood and lymphatic system disorders | — |
| Platelet Count Decreased | Investigations | — |
| Headache | Nervous system disorders | — |
| Sinus Tachycardia | Cardiac disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Cognitive Disturbance | Nervous system disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Non-Cardiac Chest Pain | General disorders | — |
Most-reported serious reactions: Fever, Supraventricular tachycardia, Encephalopathy, Febrile neutropenia, Cytokine release syndrome, Syncope, Respiratory failure.
Data from ClinicalTrials.gov NCT05108805 adverse events section.
We hope to demonstrate that YESCARTA can be safely administered in the outpatient setting if we closely monitor subjects with physical exams, wearable devices, and telemedicine visits and only admit those who meet specified criteria
4 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
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/NCT05108805.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing