Trial Outcomes & Findings for Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma (NCT NCT04626791)
NCT ID: NCT04626791
Last Updated: 2026-07-22
Results Overview
Measured according to Lugano criteria. A success is defined as a CMR as the objective status at the end of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
ACTIVE_NOT_RECRUITING
PHASE2
41 participants
29 months
2026-07-22
Participant Flow
Participant milestones
| Measure |
Treatment (Modified VR-CAP, Acalabrutinib)
CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. \> \> CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. \>
\> Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.\>
\> Acalabrutinib: Given PO\>
\> Bortezomib: Given SC\>
\> Cyclophosphamide: Given IV\>
\> Cytarabine: Given IV\>
\> Doxorubicin Hydrochloride: Given IV\>
\> Prednisone: Given PO\>
\> Rituximab: Given IV\>
\> Rituximab and Hyaluronidase Human: Given IV
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Modified VR-CAP, Acalabrutinib)
CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. \> \> CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. \>
\> Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.\>
\> Acalabrutinib: Given PO\>
\> Bortezomib: Given SC\>
\> Cyclophosphamide: Given IV\>
\> Cytarabine: Given IV\>
\> Doxorubicin Hydrochloride: Given IV\>
\> Prednisone: Given PO\>
\> Rituximab: Given IV\>
\> Rituximab and Hyaluronidase Human: Given IV
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Modified VR-CAP, Acalabrutinib)
n=41 Participants
CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. \> \> CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. \>
\> Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.\>
\> Acalabrutinib: Given PO\>
\> Bortezomib: Given SC\>
\> Cyclophosphamide: Given IV\>
\> Cytarabine: Given IV\>
\> Doxorubicin Hydrochloride: Given IV\>
\> Prednisone: Given PO\>
\> Rituximab: Given IV\>
\> Rituximab and Hyaluronidase Human: Given IV
|
|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 7.50 • n=9 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=9 Participants
|
|
ECOG Performance Status
0
|
20 Participants
n=9 Participants
|
|
ECOG Performance Status
1
|
20 Participants
n=9 Participants
|
|
ECOG Performance Status
2
|
1 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 29 monthsMeasured according to Lugano criteria. A success is defined as a CMR as the objective status at the end of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Outcome measures
| Measure |
Treatment (Modified VR-CAP, Acalabrutinib)
n=41 Participants
CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. \> \> CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. \>
\> Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.\>
\> Acalabrutinib: Given PO\>
\> Bortezomib: Given SC\>
\> Cyclophosphamide: Given IV\>
\> Cytarabine: Given IV\>
\> Doxorubicin Hydrochloride: Given IV\>
\> Prednisone: Given PO\>
\> Rituximab: Given IV\>
\> Rituximab and Hyaluronidase Human: Given IV
|
|---|---|
|
Proportion of Complete Responses to Therapy (Complete Metabolic Response [CMR])
|
90.2 percentage of participants
Interval 83.3 to 99.1
|
SECONDARY outcome
Timeframe: 29 monthsThe maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be reported.
Outcome measures
| Measure |
Treatment (Modified VR-CAP, Acalabrutinib)
n=41 Participants
CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. \> \> CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. \>
\> Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.\>
\> Acalabrutinib: Given PO\>
\> Bortezomib: Given SC\>
\> Cyclophosphamide: Given IV\>
\> Cytarabine: Given IV\>
\> Doxorubicin Hydrochloride: Given IV\>
\> Prednisone: Given PO\>
\> Rituximab: Given IV\>
\> Rituximab and Hyaluronidase Human: Given IV
|
|---|---|
|
Number of Patients Experiencing at Least One Grade 3 or Greater Adverse Event
|
33 Participants
|
SECONDARY outcome
Timeframe: 15 monthsThe proportion of patients alive and progression free with 95% CI will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Modified VR-CAP, Acalabrutinib)
n=41 Participants
CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. \> \> CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. \>
\> Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.\>
\> Acalabrutinib: Given PO\>
\> Bortezomib: Given SC\>
\> Cyclophosphamide: Given IV\>
\> Cytarabine: Given IV\>
\> Doxorubicin Hydrochloride: Given IV\>
\> Prednisone: Given PO\>
\> Rituximab: Given IV\>
\> Rituximab and Hyaluronidase Human: Given IV
|
|---|---|
|
Progression-free Survival
|
87.5 percentage of participants
Interval 75.2 to 100.0
|
SECONDARY outcome
Timeframe: 18 monthsThe proportion of participants alive and 95% CI will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Modified VR-CAP, Acalabrutinib)
n=41 Participants
CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. \> \> CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. \>
\> Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.\>
\> Acalabrutinib: Given PO\>
\> Bortezomib: Given SC\>
\> Cyclophosphamide: Given IV\>
\> Cytarabine: Given IV\>
\> Doxorubicin Hydrochloride: Given IV\>
\> Prednisone: Given PO\>
\> Rituximab: Given IV\>
\> Rituximab and Hyaluronidase Human: Given IV
|
|---|---|
|
Overall Survival
|
95.8 percentage of participants
Interval 88.1 to 100.0
|
SECONDARY outcome
Timeframe: 29 monthsThe proportion of patients successfully collecting at least 2 x 10\^6 CD34 cells/kg pt body weight will be calculated and reported.
Outcome measures
| Measure |
Treatment (Modified VR-CAP, Acalabrutinib)
n=41 Participants
CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. \> \> CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. \>
\> Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.\>
\> Acalabrutinib: Given PO\>
\> Bortezomib: Given SC\>
\> Cyclophosphamide: Given IV\>
\> Cytarabine: Given IV\>
\> Doxorubicin Hydrochloride: Given IV\>
\> Prednisone: Given PO\>
\> Rituximab: Given IV\>
\> Rituximab and Hyaluronidase Human: Given IV
|
|---|---|
|
Feasibility of Stem Cell Collection
|
9 Participants
|
SECONDARY outcome
Timeframe: 29 monthsPopulation: Only patients that proceeded to ASCT are included in analysis
The feasibility of stem cell collection will be determined by the proportion of patients successfully collecting at least 2 x 10\^6 CD34 cells/kg pt body weight divided by the total number of evaluable patients proceeding to ASCT.
Outcome measures
| Measure |
Treatment (Modified VR-CAP, Acalabrutinib)
n=9 Participants
CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. \> \> CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. \>
\> Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.\>
\> Acalabrutinib: Given PO\>
\> Bortezomib: Given SC\>
\> Cyclophosphamide: Given IV\>
\> Cytarabine: Given IV\>
\> Doxorubicin Hydrochloride: Given IV\>
\> Prednisone: Given PO\>
\> Rituximab: Given IV\>
\> Rituximab and Hyaluronidase Human: Given IV
|
|---|---|
|
Successful Proceeding to Autologous Stem Cell Transplant (ASCT)
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to completion of study treatmentMeasured by sequencing. MRD results will be reported descriptively, and explored for correlation with clinical factors and patient outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to completion of study treatmentMeasured by flow. MRD results will be reported descriptively, and explored for correlation with clinical factors and patient outcomes.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Modified VR-CAP, Acalabrutinib)
Serious adverse events
| Measure |
Treatment (Modified VR-CAP, Acalabrutinib)
n=41 participants at risk
Rituximab and Hyaluronidase Human: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.8%
4/41 • Number of events 4 • 29 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • Number of events 2 • 29 months
|
|
Cardiac disorders
Cardiac arrest
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Infections and infestations
Lung infection
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Investigations
Platelet count decreased
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Nervous system disorders
Dizziness
|
2.4%
1/41 • Number of events 2 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/41 • Number of events 1 • 29 months
|
Other adverse events
| Measure |
Treatment (Modified VR-CAP, Acalabrutinib)
n=41 participants at risk
Rituximab and Hyaluronidase Human: Given IV
|
|---|---|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.5%
8/41 • Number of events 26 • 29 months
|
|
Nervous system disorders
Presyncope
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Nervous system disorders
Syncope
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Nervous system disorders
Vasovagal reaction
|
4.9%
2/41 • Number of events 2 • 29 months
|
|
Psychiatric disorders
Anxiety
|
2.4%
1/41 • Number of events 2 • 29 months
|
|
Psychiatric disorders
Insomnia
|
4.9%
2/41 • Number of events 7 • 29 months
|
|
Reproductive system and breast disorders
Vaginal dryness
|
2.4%
1/41 • Number of events 2 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
3/41 • Number of events 4 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.3%
3/41 • Number of events 3 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.9%
2/41 • Number of events 3 • 29 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.3%
3/41 • Number of events 5 • 29 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
4.9%
2/41 • Number of events 3 • 29 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.9%
2/41 • Number of events 3 • 29 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
2.4%
1/41 • Number of events 2 • 29 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.4%
1/41 • Number of events 2 • 29 months
|
|
Vascular disorders
Flushing
|
2.4%
1/41 • Number of events 3 • 29 months
|
|
Blood and lymphatic system disorders
Anemia
|
39.0%
16/41 • Number of events 26 • 29 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Cardiac disorders
Palpitations
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Cardiac disorders
Sinus tachycardia
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Bloating
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Constipation
|
4.9%
2/41 • Number of events 3 • 29 months
|
|
Gastrointestinal disorders
Diarrhea
|
4.9%
2/41 • Number of events 2 • 29 months
|
|
Gastrointestinal disorders
Dry mouth
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Gastrointestinal disorders
Mucositis oral
|
4.9%
2/41 • Number of events 2 • 29 months
|
|
Gastrointestinal disorders
Nausea
|
19.5%
8/41 • Number of events 14 • 29 months
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
4/41 • Number of events 4 • 29 months
|
|
General disorders and administration site conditions
Fatigue
|
7.3%
3/41 • Number of events 8 • 29 months
|
|
General disorders and administration site conditions
Fever
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
General disorders and administration site conditions
Flu like symptoms
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
General disorders and administration site conditions
Injection site reaction
|
4.9%
2/41 • Number of events 3 • 29 months
|
|
Infections and infestations
Conjunctivitis
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Infections and infestations
Conjunctivitis infective
|
2.4%
1/41 • Number of events 3 • 29 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
12.2%
5/41 • Number of events 8 • 29 months
|
|
Infections and infestations
Skin infection
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Infections and infestations
Thrush
|
9.8%
4/41 • Number of events 4 • 29 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
53.7%
22/41 • Number of events 32 • 29 months
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
2.4%
1/41 • Number of events 2 • 29 months
|
|
Investigations
Alanine aminotransferase increased
|
4.9%
2/41 • Number of events 3 • 29 months
|
|
Investigations
Creatinine increased
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Investigations
Neutrophil count decreased
|
34.1%
14/41 • Number of events 20 • 29 months
|
|
Investigations
Platelet count decreased
|
70.7%
29/41 • Number of events 70 • 29 months
|
|
Investigations
Weight loss
|
7.3%
3/41 • Number of events 8 • 29 months
|
|
Investigations
White blood cell decreased
|
2.4%
1/41 • Number of events 2 • 29 months
|
|
Metabolism and nutrition disorders
Anorexia
|
4.9%
2/41 • Number of events 4 • 29 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.9%
2/41 • Number of events 2 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41 • Number of events 6 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Nervous system disorders
Akathisia
|
2.4%
1/41 • Number of events 1 • 29 months
|
|
Nervous system disorders
Headache
|
17.1%
7/41 • Number of events 14 • 29 months
|
Additional Information
Stephen D. Smith M. D.
University of Washington/Fred Hutchinson Cancer Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place