Trial Outcomes & Findings for Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas (NCT NCT00783367)

NCT ID: NCT00783367

Last Updated: 2023-03-30

Results Overview

Response rate is defined as a complete response or partial response using anatomic criteria of the International Workshop Response Critieria (Cheson, 1999).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-03-30

Participant Flow

Participant milestones

Measure	Cohort 1 Revlimid + rituximab with dexamethasone	Cohort 2 Revlimid + rituximab (without dexamethasone)
Overall Study STARTED	27	23
Overall Study COMPLETED	27	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas

Baseline characteristics by cohort

Measure	Cohort 1 n=27 Participants Revlimid + rituximab with dexamethasone	Cohort 2 n=23 Participants Revlimid + rituximab (without dexamethasone)	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	00 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Response rate is defined as a complete response or partial response using anatomic criteria of the International Workshop Response Critieria (Cheson, 1999).

Outcome measures

Measure	Cohort 1 n=24 Participants Revlimid + rituximab with dexamethasone	Cohort 2 n=19 Participants Revlimid + rituximab (without dexamethasone)
Response Rate to Lenalidomide-dexamethasone + Rituximab Therapy in Relapsed Small B-cell Lymphoma With Rituximab Resistance	14 Participants	13 Participants

SECONDARY outcome

Timeframe: 9 years from enrollment of first subject

Population: Subjects who received both Revlimid and rituximab were evaluable for response

Progression free survival time in months

Outcome measures

Measure	Cohort 1 n=26 Participants Revlimid + rituximab with dexamethasone	Cohort 2 n=19 Participants Revlimid + rituximab (without dexamethasone)
Time Until Progression After Lenalidomide-dexamethasone + Rituximab Therapy in Relapsed Small B-cell Lymphomas With Rituximab Resistance	22.2 months Interval 11.4 to 60.8	22.4 months Interval 7.7 to 30.1

Adverse Events

Cohort 1

Serious events: 12 serious events

Other events: 27 other events

Deaths: 3 deaths

Cohort 2

Serious events: 9 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 1 n=27 participants at risk Revlimid + rituximab with dexamethasone	Cohort 2 n=23 participants at risk Revlimid + rituximab (without dexamethasone)
Investigations Neutrophil count decreased	7.4% 2/27 • Number of events 3 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	17.4% 4/23 • Number of events 4 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Vascular disorders Thromboembolic event	7.4% 2/27 • Number of events 2 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Renal and urinary disorders urinary retention	3.7% 1/27 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Infections and infestations lung infection	3.7% 1/27 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
General disorders fever	0.00% 0/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	8.7% 2/23 • Number of events 2 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Respiratory, thoracic and mediastinal disorders Respiratory Failure	3.7% 1/27 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
General disorders General disorders and administration site conditions, other: tumor flare	0.00% 0/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	4.3% 1/23 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant, and unspecified, Other: unrelated second malignancies	7.4% 2/27 • Number of events 2 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	4.3% 1/23 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Infections and infestations Pelvic Infection	0.00% 0/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	4.3% 1/23 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Metabolism and nutrition disorders Hyperuricemia	3.7% 1/27 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Metabolism and nutrition disorders hypokalemia	0.00% 0/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	4.3% 1/23 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Infections and infestations Infections and infestations - Other: infection of aerodigestive tract	3.7% 1/27 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Immune system disorders allergic reaction	0.00% 0/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	4.3% 1/23 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Cardiac disorders myocardial infarction	3.7% 1/27 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	4.3% 1/23 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Endocrine disorders Hypothyroidism	3.7% 1/27 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Nervous system disorders syncope	0.00% 0/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	4.3% 1/23 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Blood and lymphatic system disorders febrile neutropenia	3.7% 1/27 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Metabolism and nutrition disorders dehydration	0.00% 0/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	4.3% 1/23 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Cardiac disorders myocarditis	3.7% 1/27 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Renal and urinary disorders acute kidney injury	3.7% 1/27 • Number of events 1 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy

Other adverse events

Measure	Cohort 1 n=27 participants at risk Revlimid + rituximab with dexamethasone	Cohort 2 n=23 participants at risk Revlimid + rituximab (without dexamethasone)
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 2/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Investigations Neutrophil count decreased	22.2% 6/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	39.1% 9/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Gastrointestinal disorders Constipation	33.3% 9/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	30.4% 7/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Respiratory, thoracic and mediastinal disorders Cough	14.8% 4/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	13.0% 3/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Musculoskeletal and connective tissue disorders Myalgias	33.3% 9/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	30.4% 7/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Gastrointestinal disorders Diarrhea	33.3% 9/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	43.5% 10/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
General disorders Fatigue	74.1% 20/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	52.2% 12/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Gastrointestinal disorders dyspepsia	14.8% 4/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	8.7% 2/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Respiratory, thoracic and mediastinal disorders hoarseness	0.00% 0/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	8.7% 2/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Metabolism and nutrition disorders Hypokalemia	14.8% 4/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	13.0% 3/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Gastrointestinal disorders Nausea	22.2% 6/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	21.7% 5/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Nervous system disorders Peripheral sensory neuropathy	14.8% 4/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	17.4% 4/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Investigations Platelet count decreased	11.1% 3/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	13.0% 3/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Skin and subcutaneous tissue disorders Pruritis	7.4% 2/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	8.7% 2/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Skin and subcutaneous tissue disorders Rash maculo-papular	18.5% 5/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	34.8% 8/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Gastrointestinal disorders stomach pain	0.00% 0/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	8.7% 2/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
General disorders General disorders and administration site conditions, other: tumor flare	14.8% 4/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	21.7% 5/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Nervous system disorders Dysgeusia	7.4% 2/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders, other: erythema	11.1% 3/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Blood and lymphatic system disorders Anemia	14.8% 4/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Metabolism and nutrition disorders Hypophosphatemia	7.4% 2/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Psychiatric disorders Insomnia	37.0% 10/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Infections and infestations Lung infection	11.1% 3/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Infections and infestations Upper respiratory infection	7.4% 2/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Infections and infestations Urinary tract infection	7.4% 2/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy
Infections and infestations Weight loss	11.1% 3/27 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy	0.00% 0/23 • Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy

Additional Information

Ellen Napier, CRNP

University of Pennsylvania, Clinical Research Unit, Lymphoma Group

Phone: 215.279.1972

Email: Ellen.Napier@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place