Trial Outcomes & Findings for Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia (NCT NCT02997761)
NCT ID: NCT02997761
Last Updated: 2026-06-09
Results Overview
Defined as the number of participants who achieve CR according to National Comprehensive Cancer Network (NCCN) Guidelines for Acute Lymphoblastic Leukemia (ALL), Version 2.2015
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to about 3 months from start of study treatment.
Results posted on
2026-06-09
Participant Flow
Participant milestones
| Measure |
Treatment (Ibrutinib, Blinatumomab)
INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blinatumomab: Given IV Ibrutinib: Given PO
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Ibrutinib, Blinatumomab)
n=19 Participants
INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blinatumomab: Given IV Ibrutinib: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to about 3 months from start of study treatment.Defined as the number of participants who achieve CR according to National Comprehensive Cancer Network (NCCN) Guidelines for Acute Lymphoblastic Leukemia (ALL), Version 2.2015
Outcome measures
| Measure |
Treatment (Ibrutinib, Blinatumomab)
n=18 Participants
INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blinatumomab: Given IV Ibrutinib: Given PO
|
|---|---|
|
Rate of Complete Remission (CR).
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to about 8 months from start of study treatment.Number of participants with adverse events graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Outcome measures
| Measure |
Treatment (Ibrutinib, Blinatumomab)
n=19 Participants
INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blinatumomab: Given IV Ibrutinib: Given PO
|
|---|---|
|
Number of Participants With Adverse Events
|
19 Participants
|
SECONDARY outcome
Timeframe: Up to about 8 months from start of treatment.Multiparameter Flow Cytometry (MFC) minimal residual disease (MRD) negative CR/CRi rate - defined as the number of CR/CRi participants with B-ALL cells comprising \< 0.01% of bone marrow mononuclear cells \[BMMC\] as measured by flow cytometry or molecular studies.
Outcome measures
| Measure |
Treatment (Ibrutinib, Blinatumomab)
n=10 Participants
INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blinatumomab: Given IV Ibrutinib: Given PO
|
|---|---|
|
Minimal Residual Disease (MRD) Negative CR/CRi Rate
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 8 months from start of treatment.Overall response rate (ORR) - defined as CR plus CR with incomplete count recovery (CRi) according to NCCN guidelines for ALL.
Outcome measures
| Measure |
Treatment (Ibrutinib, Blinatumomab)
n=18 Participants
INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blinatumomab: Given IV Ibrutinib: Given PO
|
|---|---|
|
Overall Response Rate (ORR).
|
10 Participants
|
SECONDARY outcome
Timeframe: From the time of first study drug administration until date of death from any cause, assessed for up to about 15.6 months.Defined as the median OS measured from the time of first study drug administration until the date of progression or death from any cause.
Outcome measures
| Measure |
Treatment (Ibrutinib, Blinatumomab)
n=18 Participants
INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blinatumomab: Given IV Ibrutinib: Given PO
|
|---|---|
|
Overall Survival (OS).
|
12.3 months
Interval 7.8 to 15.6
|
SECONDARY outcome
Timeframe: Time from start of treatment to date of hematopoietic cell transplant assessed for up to 8 months.Proportion of patients bridged to allogeneic hematopoietic cell transplant (allo-HCT or CAR-T.
Outcome measures
| Measure |
Treatment (Ibrutinib, Blinatumomab)
n=18 Participants
INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blinatumomab: Given IV Ibrutinib: Given PO
|
|---|---|
|
Proportion of Patients Bridged to Allogeneic Hematopoietic Cell Transplant (Allo-HCT or CAR-T.
|
6 Participants
|
Adverse Events
Treatment (Ibrutinib, Blinatumomab)
Serious events: 8 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Ibrutinib, Blinatumomab)
n=19 participants at risk
INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blinatumomab: Given IV Ibrutinib: Given PO
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.3%
5/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Infections and infestations
Gum infection
|
5.3%
1/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Nervous system disorders
Neurotoxicity
|
5.3%
1/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Renal and urinary disorders
Renal calculi
|
5.3%
1/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Infections and infestations
Sepsis
|
5.3%
1/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
Other adverse events
| Measure |
Treatment (Ibrutinib, Blinatumomab)
n=19 participants at risk
INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blinatumomab: Given IV Ibrutinib: Given PO
|
|---|---|
|
Nervous system disorders
Headache
|
47.4%
9/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.1%
4/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Vascular disorders
Hypertension
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
21.1%
4/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
21.1%
4/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Immune system disorders
Cytokine release syndrome
|
47.4%
9/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
26.3%
5/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Nervous system disorders
Dizziness
|
31.6%
6/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
General disorders
Edema limbs
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
General disorders
Fatigue
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
26.3%
5/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
General disorders
Fever
|
57.9%
11/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Vascular disorders
Flushing
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
21.1%
4/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Investigations
Alanine aminotransferase increased
|
31.6%
6/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Investigations
Alkaline phosphatase increased
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Anemia
|
47.4%
9/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Anorexia
|
21.1%
4/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Gastrointestinal disorders
Ascites
|
21.1%
4/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.3%
5/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Investigations
Blood bilirubin increased
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Eye disorders
Blurred vision
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
General disorders
Chills
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Nervous system disorders
Cognitive disturbance
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Psychiatric disorders
Confusion
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Gastrointestinal disorders
Constipation
|
36.8%
7/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Investigations
Creatinine increased
|
21.1%
4/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Vascular disorders
Hypotension
|
26.3%
5/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Psychiatric disorders
Insomnia
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
General disorders
Localized edema
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Infections and infestations
Lung infection
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Investigations
Lymphocyte count decreased
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.1%
4/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Gastrointestinal disorders
Nausea
|
36.8%
7/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Nervous system disorders
Other, Neurotoxicity
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Investigations
Neutrophil count decreased
|
31.6%
6/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
General disorders
Non-cardiac chest pain
|
21.1%
4/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Gastrointestinal disorders
Oral pain
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
General disorders
Pain
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Nervous system disorders
Paresthesia
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Investigations
Platelet count decreased
|
36.8%
7/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Cardiac disorders
Sinus bradycardia
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Nervous system disorders
Tremor
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Renal and urinary disorders
Urinary frequency
|
10.5%
2/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Gastrointestinal disorders
Vomiting
|
26.3%
5/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
|
Investigations
White blood cell decreased
|
15.8%
3/19 • Up to about 8 months for adverse events and serious adverse events; up to about 15.6 months for all-cause mortality.
|
Additional Information
Office of Clinical Research
University of California, Davis
Phone: 916-382-6970
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place