Trial Outcomes & Findings for Addition of Etanercept and Extracorporeal Photopheresis (ECP) to Standard Graft-Versus-Host Disease (GVHD) Prophylaxis in Stem Cell Transplant (NCT NCT00639717)
NCT ID: NCT00639717
Last Updated: 2017-08-01
Results Overview
Overall survival at 6 months
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
6 months
Results posted on
2017-08-01
Participant Flow
Participant milestones
| Measure |
Etanercept and ECP
Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant.
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|---|---|
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Overall Study
STARTED
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48
|
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Overall Study
COMPLETED
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48
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Addition of Etanercept and Extracorporeal Photopheresis (ECP) to Standard Graft-Versus-Host Disease (GVHD) Prophylaxis in Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Etanercept and ECP
n=48 Participants
Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant.
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|---|---|
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Age, Continuous
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60 years
n=5 Participants
|
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Sex: Female, Male
Female
|
22 Participants
n=5 Participants
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Sex: Female, Male
Male
|
26 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 monthsOverall survival at 6 months
Outcome measures
| Measure |
Etanercept and ECP
n=48 Participants
Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant.
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|---|---|
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Percentage of Patients Alive at 6 Months
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83 percentage of patients
Interval 73.0 to 95.0
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PRIMARY outcome
Timeframe: 6 monthsRelapse rate at 6 months. Relapse is defined as recurrence of disease.
Outcome measures
| Measure |
Etanercept and ECP
n=48 Participants
Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant.
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|---|---|
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Percentage of Patients Who Experienced Relapse by 6 Months
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8 Percentage of patients
Interval 0.0 to 16.0
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SECONDARY outcome
Timeframe: 6 MonthsIncidence of acute GVHD grades 2-4 and chronic GVHD in this study population
Outcome measures
| Measure |
Etanercept and ECP
n=48 Participants
Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant.
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|---|---|
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The Percentage of Patients That Experienced Graft Versus Host Disease
|
46 percentage of patients
Interval 32.0 to 60.0
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SECONDARY outcome
Timeframe: 100 daysPopulation: Plasma markers were not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 180 daysPopulation: T cell numbers were not analyzed
Outcome measures
Outcome data not reported
Adverse Events
Etanercept and ECP
Serious events: 19 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept and ECP
n=48 participants at risk
Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant.
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|---|---|
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Blood and lymphatic system disorders
Blood Bone Marrow - Other
|
6.2%
3/48 • Number of events 3
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Cardiac disorders
Cardiac ischemia/infarction
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4.2%
2/48 • Number of events 2
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Gastrointestinal disorders
Diarrhea
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2.1%
1/48 • Number of events 1
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|
Gastrointestinal disorders
Gastrointestinal - Other
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2.1%
1/48 • Number of events 1
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|
Gastrointestinal disorders
Ileus, GI Obstruction
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2.1%
1/48 • Number of events 1
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|
Gastrointestinal disorders
Vomiting
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2.1%
1/48 • Number of events 1
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Vascular disorders
Hemorrhage, CNS
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2.1%
1/48 • Number of events 1
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Vascular disorders
Hemorrhage, GI
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2.1%
1/48 • Number of events 1
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Infections and infestations
Lung Infection
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2.1%
1/48 • Number of events 1
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Infections and infestations
Stomach Infection
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2.1%
1/48 • Number of events 1
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Nervous system disorders
Confusion
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2.1%
1/48 • Number of events 1
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Nervous system disorders
Agitation
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2.1%
1/48 • Number of events 1
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Nervous system disorders
Depression
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2.1%
1/48 • Number of events 1
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Nervous system disorders
Syncope (fainting)
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2.1%
1/48 • Number of events 1
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Cardiac disorders
Pain - Cardiac
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2.1%
1/48 • Number of events 1
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Nervous system disorders
Pain - Head
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2.1%
1/48 • Number of events 1
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Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
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2.1%
1/48 • Number of events 1
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Respiratory, thoracic and mediastinal disorders
Hypoxia
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2.1%
1/48 • Number of events 1
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Vascular disorders
Thrombosis/embolism (vascular access-related)
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2.1%
1/48 • Number of events 1
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Vascular disorders
Thrombosis/thrombus/embolism
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2.1%
1/48 • Number of events 1
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Other adverse events
| Measure |
Etanercept and ECP
n=48 participants at risk
Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant.
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|---|---|
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Blood and lymphatic system disorders
Blood Bone Marrow - Other
|
10.4%
5/48 • Number of events 5
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Cardiac disorders
Atrial Fibrillation
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8.3%
4/48 • Number of events 4
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Cardiac disorders
Cardiac ischemia/infarction
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8.3%
4/48 • Number of events 4
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Cardiac disorders
Hypertension
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8.3%
4/48 • Number of events 5
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Vascular disorders
PTT (Partial Thromboplastin Time)
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8.3%
4/48 • Number of events 6
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Gastrointestinal disorders
Ascites (non-malignant)
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6.2%
3/48 • Number of events 4
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Gastrointestinal disorders
Diarrhea
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25.0%
12/48 • Number of events 13
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Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
10.4%
5/48 • Number of events 5
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|
Gastrointestinal disorders
Nausea
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22.9%
11/48 • Number of events 11
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|
Gastrointestinal disorders
Vomiting
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8.3%
4/48 • Number of events 6
|
|
Infections and infestations
Febrile neutropenia
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27.1%
13/48 • Number of events 13
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Infections and infestations
Blood Infection with Grade 3/4 ANC
|
18.8%
9/48 • Number of events 10
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Infections and infestations
Lung Infection
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10.4%
5/48 • Number of events 6
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Infections and infestations
Urinary Tract Infection
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6.2%
3/48 • Number of events 3
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Infections and infestations
Blood Infection with Normal ANC
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16.7%
8/48 • Number of events 8
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Infections and infestations
Catheter-related Infection
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8.3%
4/48 • Number of events 5
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Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
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10.4%
5/48 • Number of events 5
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Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
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6.2%
3/48 • Number of events 4
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|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
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12.5%
6/48 • Number of events 6
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Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
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10.4%
5/48 • Number of events 6
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Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
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35.4%
17/48 • Number of events 35
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Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
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22.9%
11/48 • Number of events 18
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|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
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6.2%
3/48 • Number of events 4
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Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
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18.8%
9/48 • Number of events 11
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Musculoskeletal and connective tissue disorders
Muscle weakness, generalized
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6.2%
3/48 • Number of events 3
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Nervous system disorders
Ataxia (incoordination)
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12.5%
6/48 • Number of events 11
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|
Nervous system disorders
Confusion
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10.4%
5/48 • Number of events 5
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|
Nervous system disorders
Dizziness
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6.2%
3/48 • Number of events 3
|
|
Nervous system disorders
Anxiety
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6.2%
3/48 • Number of events 3
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
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10.4%
5/48 • Number of events 6
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Gastrointestinal disorders
Pain-Abdomen
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8.3%
4/48 • Number of events 5
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Musculoskeletal and connective tissue disorders
Pain-Back
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10.4%
5/48 • Number of events 5
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Nervous system disorders
Pain-Head
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6.2%
3/48 • Number of events 4
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Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
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12.5%
6/48 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.8%
10/48 • Number of events 14
|
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Vascular disorders
Thrombosis/thrombus/embolism
|
6.2%
3/48 • Number of events 3
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Additional Information
Dr. Gregory Yanik
University of Michigan Comprehensive Cancer Center
Phone: 734-764-3243
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place