Trial Outcomes & Findings for Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation (NCT NCT03159702)
NCT ID: NCT03159702
Last Updated: 2026-01-27
Results Overview
Progression-free survival (PFS) is defined as the interval from the date of transplantation to the earlier of the following events: (1) the first documented objective disease progression; (2) death from any cause. Subjects without documented PD/death will be censored at the earliest of the of the following times: (1) the starting time of a new treatment other than the study treatment; (2) the last efficacy assessment date.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
1 year
Results posted on
2026-01-27
Participant Flow
Participant milestones
| Measure |
MEL/FLU and Total-Body Irradiation (TBI)
For patients who are \< 60 years.
* Melphalan: 140 mg/m2/day IV on Day: -6
* Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = \[(140-age) x weight (kg) x 0.85 (for women only)\]/ \[72 x creat (mg/dl)\].)
* TBI: 200 cGy Day: -1.
For patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of \>3 (at the discretion of treating physician will have an option to receive):
* Melphalan: 70 mg/m2/day IV on Day -6.
* Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2.
* TBI: 200 cGy; Days -1.
Evomela: 140 mg/m\^2/day IV on Day -6 for patients who are \< 60 years of age. 70 mg/m\^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of \>3
Fludarabine: 40 mg/ m\^2/day intravenous on Days: -5 -4, -3, -2
Total Body Irradiation: 200 cGy on Day: -1
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation
Baseline characteristics by cohort
| Measure |
MEL/FLU and Total-Body Irradiation (TBI)
n=43 Participants
For patients who are \< 60 years.
* Melphalan: 140 mg/m2/day IV on Day: -6
* Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = \[(140-age) x weight (kg) x 0.85 (for women only)\]/ \[72 x creat (mg/dl)\].)
* TBI: 200 cGy Day: -1.
For patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of \>3 (at the discretion of treating physician will have an option to receive):
* Melphalan: 70 mg/m2/day IV on Day -6.
* Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2.
* TBI: 200 cGy; Days -1.
Evomela: 140 mg/m\^2/day IV on Day -6 for patients who are \< 60 years of age. 70 mg/m\^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of \>3
Fludarabine: 40 mg/ m\^2/day intravenous on Days: -5 -4, -3, -2
Total Body Irradiation: 200 cGy on Day: -1
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 1 yearProgression-free survival (PFS) is defined as the interval from the date of transplantation to the earlier of the following events: (1) the first documented objective disease progression; (2) death from any cause. Subjects without documented PD/death will be censored at the earliest of the of the following times: (1) the starting time of a new treatment other than the study treatment; (2) the last efficacy assessment date.
Outcome measures
| Measure |
MEL/FLU and Total-Body Irradiation (TBI)
n=43 Participants
For patients who are \< 60 years.
* Melphalan: 140 mg/m2/day IV on Day: -6
* Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = \[(140-age) x weight (kg) x 0.85 (for women only)\]/ \[72 x creat (mg/dl)\].)
* TBI: 200 cGy Day: -1.
For patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of \>3 (at the discretion of treating physician will have an option to receive):
* Melphalan: 70 mg/m2/day IV on Day -6.
* Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2.
* TBI: 200 cGy; Days -1.
Evomela: 140 mg/m\^2/day IV on Day -6 for patients who are \< 60 years of age. 70 mg/m\^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of \>3
Fludarabine: 40 mg/ m\^2/day intravenous on Days: -5 -4, -3, -2
Total Body Irradiation: 200 cGy on Day: -1
Haploidentical Hematopoietic Cell Transplantation: This is a procedure that uses healthy blood-forming cells from a half-matched donor, typically a family member, to replace a patient's unhealthy ones.
|
|---|---|
|
Progression-free Survival (PFS) of Participants With Hematological Malignancies Undergoing Treatment.
|
17 Participants
|
PRIMARY outcome
Timeframe: 2 YearsAn SAE is defined as any untoward medical occurrence at any dose, including death, life threatening, hospitalization, disability/incapacity, medically important event. The measure of this outcome is the number of participants with SAEs.
Outcome measures
| Measure |
MEL/FLU and Total-Body Irradiation (TBI)
n=43 Participants
For patients who are \< 60 years.
* Melphalan: 140 mg/m2/day IV on Day: -6
* Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = \[(140-age) x weight (kg) x 0.85 (for women only)\]/ \[72 x creat (mg/dl)\].)
* TBI: 200 cGy Day: -1.
For patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of \>3 (at the discretion of treating physician will have an option to receive):
* Melphalan: 70 mg/m2/day IV on Day -6.
* Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2.
* TBI: 200 cGy; Days -1.
Evomela: 140 mg/m\^2/day IV on Day -6 for patients who are \< 60 years of age. 70 mg/m\^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of \>3
Fludarabine: 40 mg/ m\^2/day intravenous on Days: -5 -4, -3, -2
Total Body Irradiation: 200 cGy on Day: -1
Haploidentical Hematopoietic Cell Transplantation: This is a procedure that uses healthy blood-forming cells from a half-matched donor, typically a family member, to replace a patient's unhealthy ones.
|
|---|---|
|
Serious Adverse Events (SAE).
|
12 Participants
|
SECONDARY outcome
Timeframe: 1 YearThis is the number of participants expiring without recurrent or progressive disease after transplantation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 Year and 2 YearThe number of participants still alive at one year and 2 years.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 100 and 1 YearThe number of participants who relapse following reduced-intensity conditioning haploidentical transplantation at Day 100 and 1 Year.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 30The average of the number of days that it takes for neutrophil recovery from reduced-intensity conditioning haploidentical transplantation. Neutrophil recovery means absolute neutrophil count of 0.5x10\^3 cells/uL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 30The average of the number of days that it takes for platelet recovery from reduced-intensity conditioning haploidentical transplantation. Platelet recovery means absolute neutrophil count of 50x10\^3 cells/uL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 100 and 180The number of participants with graft-versus-host disease using the Center for International Bone Marrow Transplant Research criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 YearThe number of participants with chronic GVHD at one-year post transplantation using the Center for International Bone Marrow Transplant Research criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 30Number of subjects whose grafts failed to implant.
Outcome measures
Outcome data not reported
Adverse Events
MEL/FLU and Total-Body Irradiation (TBI)
Serious events: 12 serious events
Other events: 43 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
MEL/FLU and Total-Body Irradiation (TBI)
n=43 participants at risk
For patients who are \< 60 years.
* Melphalan: 140 mg/m2/day IV on Day: -6
* Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = \[(140-age) x weight (kg) x 0.85 (for women only)\]/ \[72 x creat (mg/dl)\].)
* TBI: 200 cGy Day: -1.
For patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of \>3 (at the discretion of treating physician will have an option to receive):
* Melphalan: 70 mg/m2/day IV on Day -6.
* Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2.
* TBI: 200 cGy; Days -1.
Evomela: 140 mg/m\^2/day IV on Day -6 for patients who are \< 60 years of age. 70 mg/m\^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of \>3
Fludarabine: 40 mg/ m\^2/day intravenous on Days: -5 -4, -3, -2
Total Body Irradiation: 200 cGy on Day: -1
|
|---|---|
|
Infections and infestations
CMV Viremia
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
Infections and infestations
HHVS Virus
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.7%
2/43 • Number of events 2 • 2 Years
|
|
Immune system disorders
Cytokine release syndrome
|
4.7%
2/43 • Number of events 2 • 2 Years
|
|
Infections and infestations
Upper respiratory infection
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervical Mass
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
Infections and infestations
Sepsis
|
7.0%
3/43 • Number of events 3 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polys) - Other
|
7.0%
3/43 • Number of events 3 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Pericardial effusion
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.7%
2/43 • Number of events 2 • 2 Years
|
|
Vascular disorders
Hypotension
|
4.7%
2/43 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
General disorders
Fever
|
4.7%
2/43 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Typhlitis
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Altered mental status
|
4.7%
2/43 • Number of events 2 • 2 Years
|
|
Renal and urinary disorders
Acute kidney injury
|
4.7%
2/43 • Number of events 2 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
Vascular disorders
Thromboembolic event
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Mucositis oral
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Blood in stool
|
2.3%
1/43 • Number of events 1 • 2 Years
|
|
Investigations
Platelet count decreased
|
2.3%
1/43 • Number of events 1 • 2 Years
|
Other adverse events
| Measure |
MEL/FLU and Total-Body Irradiation (TBI)
n=43 participants at risk
For patients who are \< 60 years.
* Melphalan: 140 mg/m2/day IV on Day: -6
* Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = \[(140-age) x weight (kg) x 0.85 (for women only)\]/ \[72 x creat (mg/dl)\].)
* TBI: 200 cGy Day: -1.
For patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of \>3 (at the discretion of treating physician will have an option to receive):
* Melphalan: 70 mg/m2/day IV on Day -6.
* Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2.
* TBI: 200 cGy; Days -1.
Evomela: 140 mg/m\^2/day IV on Day -6 for patients who are \< 60 years of age. 70 mg/m\^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of \>3
Fludarabine: 40 mg/ m\^2/day intravenous on Days: -5 -4, -3, -2
Total Body Irradiation: 200 cGy on Day: -1
|
|---|---|
|
General disorders
Chills
|
27.9%
12/43 • Number of events 18 • 2 Years
|
|
Gastrointestinal disorders
Constipation
|
34.9%
15/43 • Number of events 18 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.3%
7/43 • Number of events 10 • 2 Years
|
|
Investigations
Creatinine increased
|
41.9%
18/43 • Number of events 37 • 2 Years
|
|
Gastrointestinal disorders
Diarrhea
|
88.4%
38/43 • Number of events 86 • 2 Years
|
|
Nervous system disorders
Dysgeusia
|
11.6%
5/43 • Number of events 8 • 2 Years
|
|
Gastrointestinal disorders
Dyspepsia
|
18.6%
8/43 • Number of events 8 • 2 Years
|
|
Gastrointestinal disorders
Dysphagia
|
16.3%
7/43 • Number of events 9 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
41.9%
18/43 • Number of events 31 • 2 Years
|
|
General disorders
Edema limbs
|
46.5%
20/43 • Number of events 28 • 2 Years
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
11.6%
5/43 • Number of events 10 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.6%
11/43 • Number of events 12 • 2 Years
|
|
General disorders
Fatigue
|
65.1%
28/43 • Number of events 55 • 2 Years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
58.1%
25/43 • Number of events 32 • 2 Years
|
|
Gastrointestinal disorders
Fecal incontinence
|
30.2%
13/43 • Number of events 20 • 2 Years
|
|
General disorders
Fever
|
51.2%
22/43 • Number of events 37 • 2 Years
|
|
Vascular disorders
Flushing
|
14.0%
6/43 • Number of events 7 • 2 Years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.0%
6/43 • Number of events 9 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
18.6%
8/43 • Number of events 9 • 2 Years
|
|
Psychiatric disorders
Hallucinations
|
9.3%
4/43 • Number of events 4 • 2 Years
|
|
Nervous system disorders
Headache
|
46.5%
20/43 • Number of events 38 • 2 Years
|
|
Renal and urinary disorders
Hematuria
|
27.9%
12/43 • Number of events 15 • 2 Years
|
|
Gastrointestinal disorders
Hemorrhoids
|
25.6%
11/43 • Number of events 11 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
9.3%
4/43 • Number of events 4 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.2%
13/43 • Number of events 23 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
23.3%
10/43 • Number of events 21 • 2 Years
|
|
Vascular disorders
Hypertension
|
48.8%
21/43 • Number of events 61 • 2 Years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
14.0%
6/43 • Number of events 12 • 2 Years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
55.8%
24/43 • Number of events 47 • 2 Years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
60.5%
26/43 • Number of events 70 • 2 Years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
62.8%
27/43 • Number of events 71 • 2 Years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
69.8%
30/43 • Number of events 49 • 2 Years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
53.5%
23/43 • Number of events 54 • 2 Years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
53.5%
23/43 • Number of events 46 • 2 Years
|
|
Vascular disorders
Hypotension
|
44.2%
19/43 • Number of events 54 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
18.6%
8/43 • Number of events 14 • 2 Years
|
|
Psychiatric disorders
Insomnia
|
27.9%
12/43 • Number of events 20 • 2 Years
|
|
Investigations
Lymphocyte count decreased
|
69.8%
30/43 • Number of events 66 • 2 Years
|
|
Gastrointestinal disorders
Mucositis oral
|
39.5%
17/43 • Number of events 23 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.0%
6/43 • Number of events 8 • 2 Years
|
|
Gastrointestinal disorders
Nausea
|
86.0%
37/43 • Number of events 72 • 2 Years
|
|
Investigations
Neutrophil count decreased
|
72.1%
31/43 • Number of events 107 • 2 Years
|
|
General disorders
Non-cardiac chest pain
|
11.6%
5/43 • Number of events 7 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.3%
7/43 • Number of events 10 • 2 Years
|
|
Cardiac disorders
Pericardial effusion
|
9.3%
4/43 • Number of events 5 • 2 Years
|
|
Investigations
Platelet count decreased
|
81.4%
35/43 • Number of events 167 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.6%
5/43 • Number of events 7 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.3%
4/43 • Number of events 7 • 2 Years
|
|
Renal and urinary disorders
Proteinuria
|
9.3%
4/43 • Number of events 13 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.2%
13/43 • Number of events 18 • 2 Years
|
|
Renal and urinary disorders
Dysuria
|
9.3%
4/43 • Number of events 5 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
9.3%
4/43 • Number of events 6 • 2 Years
|
|
Cardiac disorders
Sinus tachycardia
|
39.5%
17/43 • Number of events 35 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.9%
9/43 • Number of events 16 • 2 Years
|
|
Nervous system disorders
Tremor
|
14.0%
6/43 • Number of events 9 • 2 Years
|
|
Renal and urinary disorders
Urinary frequency
|
27.9%
12/43 • Number of events 18 • 2 Years
|
|
Renal and urinary disorders
Urinary incontinence
|
25.6%
11/43 • Number of events 13 • 2 Years
|
|
Renal and urinary disorders
Urinary urgency
|
14.0%
6/43 • Number of events 8 • 2 Years
|
|
Gastrointestinal disorders
Vomiting
|
44.2%
19/43 • Number of events 36 • 2 Years
|
|
Investigations
Weight gain
|
9.3%
4/43 • Number of events 11 • 2 Years
|
|
Investigations
Weight loss
|
16.3%
7/43 • Number of events 7 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.3%
7/43 • Number of events 11 • 2 Years
|
|
Investigations
White blood cell decreased
|
65.1%
28/43 • Number of events 107 • 2 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
39.5%
17/43 • Number of events 33 • 2 Years
|
|
Renal and urinary disorders
Acute kidney injury
|
16.3%
7/43 • Number of events 16 • 2 Years
|
|
Investigations
Alanine aminotransferase increased
|
18.6%
8/43 • Number of events 16 • 2 Years
|
|
Investigations
Alkaline phosphatase increased
|
9.3%
4/43 • Number of events 13 • 2 Years
|
|
Gastrointestinal disorders
Anal pain
|
11.6%
5/43 • Number of events 6 • 2 Years
|
|
Blood and lymphatic system disorders
Anemia
|
72.1%
31/43 • Number of events 87 • 2 Years
|
|
Metabolism and nutrition disorders
Anorexia
|
46.5%
20/43 • Number of events 42 • 2 Years
|
|
Investigations
Aspartate aminotransferase increased
|
18.6%
8/43 • Number of events 18 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.9%
9/43 • Number of events 9 • 2 Years
|
|
Renal and urinary disorders
Bladder spasm
|
14.0%
6/43 • Number of events 6 • 2 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place