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Alpha 1 Anti-Trypsin (AAT) in Treating Patients With Acute Graft-Versus-Host Disease GVHD)

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ClinicalTrials.gov Identifier: NCT01523821
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : October 30, 2018
Last Update Posted : October 30, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Graft-Versus-Host Disease (GVHD) Acute on Chronic
Intervention Drug: Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]
Enrollment 20

Recruitment Details Patients signed IRB-approved consents during the period of 12/11/13 to 12/22/16. Treatment with alpha 1 anti-trypsin (AAT) typically started within 24 hours of consent. Patients were identified by clinical staff as needing additional treatment for acute graft versus his disease (GVHD) following initial therapy with corticosteroids.
Pre-assignment Details  
Arm/Group Title Cohort 1 (30 mg/kg) Cohort 2 (60 mg/kg) Cohort 3 (90 mg/kg)
Hide Arm/Group Description

AAT will administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 30mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 60 mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg on days 1, 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

Period Title: Overall Study
Started 8 6 6
Completed 8 6 6
Not Completed 0 0 0
Arm/Group Title Cohort 1 (30 mg/kg) Cohort 2 (60 mg/kg) Cohort 3 (90 mg/kg) Total
Hide Arm/Group Description

AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 30mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 60 mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg on days 1, 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

Total of all reporting groups
Overall Number of Baseline Participants 8 6 6 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 6 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
4
  66.7%
6
 100.0%
18
  90.0%
>=65 years
0
   0.0%
2
  33.3%
0
   0.0%
2
  10.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 6 participants 6 participants 20 participants
49
(23 to 59)
40
(26 to 73)
51
(38 to 63)
48
(23 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 6 participants 20 participants
Female
3
  37.5%
0
   0.0%
6
 100.0%
9
  45.0%
Male
5
  62.5%
6
 100.0%
0
   0.0%
11
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 6 participants 6 participants 20 participants
8 6 6 20
1.Primary Outcome
Title Number (Percentage) of Patients at Each Dosing Cohort Who Experience no Toxicity and in Whom Graft Versus Host Disease (GVHD) is Stable or Improved
Hide Description Toxicity and adverse events were assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All adverse events were reported regardless of attribution to alpha 1 anti-trypsin (AAT). GVHD response was defined per standard criteria for improvement, no change or progression of signs/symptoms in skin rash (% body surface area), GI (nausea, vomiting, anorexia, diarrhea, GI bleeding, abdominal cramping) and hepatic function (serum bilirubin levels). For this outcome measure, the requirement for additional GVHD treatment beyond AAT was not included in the criteria for response (i.e patients who may have required additional GVHD treatment before study day 28 were not automatically categorized as non-responders or as having progressive GVHD).
Time Frame Adverse events were reported through 15 days after the last dose of AAT. GVHD response assessed at study day 28.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 (30 mg/kg) Cohort 2 (60 mg/kg) Cohort 3 (90 mg/kg)
Hide Arm/Group Description:

AAT will administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 30mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 60 mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg on days 1, 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

Overall Number of Participants Analyzed 8 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
6
  75.0%
2
  33.3%
2
  33.3%
2.Secondary Outcome
Title Number (Percentage) of Patients at Each Dosing Cohort Experiencing an Unexpected Serious Adverse Event (SAE)
Hide Description Serious adverse events included death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/ incapacity, or congenital anomaly/birth defect. Significant events that do not meet these criteria may be considered serious if they jeopardize the patient and require a medical intervention to prevent one of the outcomes above. An “unexpected” adverse event is defined as an event that is not identified in nature, severity or frequency in the current investigator brochure/package insert/product information.
Time Frame SAEs were reported through 30 days after the last dose of alpha 1 anti-trypsin (AAT).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 (30 mg/kg) Cohort 2 (60 mg/kg) Cohort 3 (90 mg/kg)
Hide Arm/Group Description:

AAT will administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 30mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 60 mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg on days 1, 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

Overall Number of Participants Analyzed 8 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
2
  25.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Number (Percentage) of Patients at Each Dosing Cohort Who Experience One or More Suspected Serious Adverse Reactions (Infusion Related Reactions)
Hide Description Serious adverse reactions were assessed by the NCI CTCAE v4.0.
Time Frame Within 48 hours after each infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 (30 mg/kg) Cohort 2 (60 mg/kg) Cohort 3 (90 mg/kg)
Hide Arm/Group Description:

AAT will administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 30mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 60 mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg on days 1, 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

Overall Number of Participants Analyzed 8 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Number (Percentage) of Patients at Each Dosing Cohort Who Experience One or More Thrombotic or Thrombo-embolic Events
Hide Description Events were assessed using the NCI CTCAE v4.0.
Time Frame Events were reported through 15 days after the last dose of AAT.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 (30 mg/kg) Cohort 2 (60 mg/kg) Cohort 3 (90 mg/kg)
Hide Arm/Group Description:

AAT will administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 30mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 60 mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg on days 1, 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

Overall Number of Participants Analyzed 8 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number (Percentage) of Patients at Each Dosing Cohort With Occurrence of Infections
Hide Description Infections were assessed using NCI CTCAE v4.0.
Time Frame Infections were reported through 15 days after the last dose of AAT.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 (30 mg/kg) Cohort 2 (60 mg/kg) Cohort 3 (90 mg/kg)
Hide Arm/Group Description:

AAT will administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 30mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 60 mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg on days 1, 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

Overall Number of Participants Analyzed 8 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
7
  87.5%
5
  83.3%
5
  83.3%
6.Secondary Outcome
Title Number (Percentage) of Patients at Each Dosing Cohort With Progression of GVHD
Hide Description GVHD responses were assessed using criteria established by the Center for International Blood and Marrow Transplant Research and criteria from the Acute GVHD Activity Index. Patients who required additional systemic GVHD treatment beyond AAT before study day 28 were defined as having progressive GVHD.
Time Frame GVHD responses were assessed on day 28 after starting AAT therapy or at time of death if patient died before study day 28.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 (30 mg/kg) Cohort 2 (60 mg/kg) Cohort 3 (90 mg/kg)
Hide Arm/Group Description:

AAT will administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 30mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 60 mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg on days 1, 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

Overall Number of Participants Analyzed 8 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
4
  50.0%
5
  83.3%
4
  66.7%
Time Frame Adverse events were reported through 15 days after the last dose of AAT. Serious adverse events were reported if they occurred within 30 days after the last dose of AAT.
Adverse Event Reporting Description All adverse events were collected regardless of attribution to AAT. Included are events that worsened from baseline.
 
Arm/Group Title Cohort 1 (30 mg/kg) Cohort 2 (60 mg/kg) Cohort 3 (90 mg/kg)
Hide Arm/Group Description

AAT will administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 30mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg (loading dose) on day 1 followed by 60 mg/kg (maintenance dose) QOD on days 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

AAT will be administered intravenously at a dose of 90 mg/kg on days 1, 3, 5, 7, 9, 11, 13 & 15.

Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]

All-Cause Mortality
Cohort 1 (30 mg/kg) Cohort 2 (60 mg/kg) Cohort 3 (90 mg/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/8 (75.00%)   4/6 (66.67%)   4/6 (66.67%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 (30 mg/kg) Cohort 2 (60 mg/kg) Cohort 3 (90 mg/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   5/6 (83.33%)   4/6 (66.67%) 
Gastrointestinal disorders       
perirectal abbess   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
bowel perforation   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
Hepatobiliary disorders       
liver failure   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
Immune system disorders       
acute graft-versus-host disease   2/8 (25.00%)  4/6 (66.67%)  3/6 (50.00%) 
Infections and infestations       
infection   1/8 (12.50%)  1/6 (16.67%)  1/6 (16.67%) 
Nervous system disorders       
cranial hemorrhage   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
Reproductive system and breast disorders       
diffuse alveolar hemorrhage   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 (30 mg/kg) Cohort 2 (60 mg/kg) Cohort 3 (90 mg/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   6/6 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders       
thrombocytopenia   6/8 (75.00%)  6/6 (100.00%)  4/6 (66.67%) 
hypogammaglobulinemia   2/8 (25.00%)  2/6 (33.33%)  2/6 (33.33%) 
neutropenia   3/8 (37.50%)  4/6 (66.67%)  3/6 (50.00%) 
anemia   2/8 (25.00%)  5/6 (83.33%)  1/6 (16.67%) 
leukocytosis   2/8 (25.00%)  2/6 (33.33%)  1/6 (16.67%) 
HUS/microangiopathy   2/8 (25.00%)  1/6 (16.67%)  2/6 (33.33%) 
acute myelogenous leukemia   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
Cardiac disorders       
edema/fluid overload   5/8 (62.50%)  5/6 (83.33%)  5/6 (83.33%) 
hypotension   1/8 (12.50%)  2/6 (33.33%)  2/6 (33.33%) 
orthostatic hypotension   1/8 (12.50%)  3/6 (50.00%)  1/6 (16.67%) 
bradycardia   1/8 (12.50%)  0/6 (0.00%)  1/6 (16.67%) 
hypertension   2/8 (25.00%)  3/6 (50.00%)  0/6 (0.00%) 
tachycardia   1/8 (12.50%)  1/6 (16.67%)  2/6 (33.33%) 
dehydration   0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
atrial fibrillation   0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Ear and labyrinth disorders       
hearing loss   0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Eye disorders       
dry eyes   1/8 (12.50%)  0/6 (0.00%)  1/6 (16.67%) 
blurred vision   1/8 (12.50%)  1/6 (16.67%)  0/6 (0.00%) 
scleral discharge   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
corneal abrasion   0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Gastrointestinal disorders       
gastroesophageal reflux   1/8 (12.50%)  1/6 (16.67%)  1/6 (16.67%) 
constipation   2/8 (25.00%)  1/6 (16.67%)  0/6 (0.00%) 
diarrhea   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
nausea   2/8 (25.00%)  0/6 (0.00%)  0/6 (0.00%) 
hemorrhoids   2/8 (25.00%)  0/6 (0.00%)  0/6 (0.00%) 
peri-rectal abcess   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
gastroparesis   0/8 (0.00%)  2/6 (33.33%)  0/6 (0.00%) 
peri-rectal irritation   0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
dry mouth   1/8 (12.50%)  3/6 (50.00%)  2/6 (33.33%) 
oral lesion/ulcer   2/8 (25.00%)  0/6 (0.00%)  0/6 (0.00%) 
oral plaques   0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
bowel perforation   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders       
pain (all sites combined)   4/8 (50.00%)  2/6 (33.33%)  2/6 (33.33%) 
facial/neck swelling   1/8 (12.50%)  1/6 (16.67%)  0/6 (0.00%) 
fatigue   4/8 (50.00%)  5/6 (83.33%)  4/6 (66.67%) 
chills   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
insomnia   1/8 (12.50%)  4/6 (66.67%)  1/6 (16.67%) 
hiccups   2/8 (25.00%)  1/6 (16.67%)  0/6 (0.00%) 
Hepatobiliary disorders       
gall bladder sludge   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
elevated liver function tests   2/8 (25.00%)  4/6 (66.67%)  0/6 (0.00%) 
iron overload   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
ascites   0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
hepatomegaly   0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
liver failure   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
Immune system disorders       
acute graft versus host disease (GVHD)   2/8 (25.00%)  4/6 (66.67%)  3/6 (50.00%) 
Infections and infestations       
infection   7/8 (87.50%)  5/6 (83.33%)  5/6 (83.33%) 
Metabolism and nutrition disorders       
hyperglycemia   3/8 (37.50%)  2/6 (33.33%)  3/6 (50.00%) 
hypokalemia   5/8 (62.50%)  2/6 (33.33%)  1/6 (16.67%) 
hyperkalemia   1/8 (12.50%)  1/6 (16.67%)  0/6 (0.00%) 
hypomagnesemia   6/8 (75.00%)  1/6 (16.67%)  3/6 (50.00%) 
hyponatremia   2/8 (25.00%)  2/6 (33.33%)  0/6 (0.00%) 
elevated LDH   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
hypocalcemia   0/8 (0.00%)  1/6 (16.67%)  2/6 (33.33%) 
hypoglycemia   0/8 (0.00%)  0/6 (0.00%)  3/6 (50.00%) 
hypophosphatemia   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders       
weakness   6/8 (75.00%)  5/6 (83.33%)  5/6 (83.33%) 
joint pain   1/8 (12.50%)  1/6 (16.67%)  0/6 (0.00%) 
fall   0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Nervous system disorders       
dizziness   2/8 (25.00%)  1/6 (16.67%)  0/6 (0.00%) 
neuropathy   2/8 (25.00%)  0/6 (0.00%)  0/6 (0.00%) 
tremor   2/8 (25.00%)  1/6 (16.67%)  0/6 (0.00%) 
altered mental status   1/8 (12.50%)  2/6 (33.33%)  1/6 (16.67%) 
seizure   1/8 (12.50%)  1/6 (16.67%)  0/6 (0.00%) 
headache   2/8 (25.00%)  1/6 (16.67%)  1/6 (16.67%) 
somnolence   0/8 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
numbness (leg)   0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
cranial hemorrhage   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
Psychiatric disorders       
anxiety/stress   4/8 (50.00%)  1/6 (16.67%)  0/6 (0.00%) 
depression   3/8 (37.50%)  1/6 (16.67%)  2/6 (33.33%) 
delirium   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
lethargy   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders       
dysuria   2/8 (25.00%)  1/6 (16.67%)  1/6 (16.67%) 
scrotal edema   1/5 (20.00%)  2/6 (33.33%)  0/0 
hematuria   0/8 (0.00%)  2/6 (33.33%)  0/6 (0.00%) 
acute kidney injury   3/8 (37.50%)  2/6 (33.33%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
hypoxia   1/8 (12.50%)  1/6 (16.67%)  0/6 (0.00%) 
cough   2/8 (25.00%)  0/6 (0.00%)  0/6 (0.00%) 
pneumonia   0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
consolidation (on CXR)   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
diffuse alveolar hemorrhage   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders       
blister/excoriation   3/8 (37.50%)  1/6 (16.67%)  0/6 (0.00%) 
dry skin   1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%) 
rash/erythema   3/8 (37.50%)  3/6 (50.00%)  0/6 (0.00%) 
striae   0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
wound   0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
penile lesion   1/5 (20.00%)  1/6 (16.67%)  0/0 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: H. Joachim Deeg, MD
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-5985
Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01523821     History of Changes
Other Study ID Numbers: 2571.00
NCI-2011-03805 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2571
2571.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P01HL036444 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: January 23, 2012
First Posted: February 1, 2012
Results First Submitted: May 10, 2018
Results First Posted: October 30, 2018
Last Update Posted: October 30, 2018