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Plerixafor and Sargramostim (GM-CSF) for Mobilization of Allogeneic Sibling Donors

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ClinicalTrials.gov Identifier: NCT01158118
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : May 3, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Lymphoma, Non-Hodgkin
Hodgkin Disease
Leukemia, Lymphocytic, Chronic, B-Cell
Multiple Myeloma
Interventions Drug: Sargramostim
Drug: Plerixafor
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
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Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)

Day 5: Mobilization with 320 mcg/kg plerixafor IV

Day 5: Leukopheresis

If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6.

Conditioning Regimens

  • fludarabine and busulfan +/- thymoglobulin
  • fractionated total body irradiation and cyclophosphamide
  • busulfan and cyclophosphamide
  • single dose total body irradiation and cyclophosphamide

Day -2 = GvHD prophylaxis

Day 0 or +1 = PBSC transplant

Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day

Period Title: Overall Study
Started 24 24
Completed 23 21
Not Completed 1 3
Reason Not Completed
Screen failure             1             0
Donor match was a screen failure             0             1
Suffered stroke prior to transplant             0             1
Death             0             1
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient Total
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Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)

Day 5: Mobilization with 320 mcg/kg plerixafor IV

Day 5: Leukopheresis

If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6.

Conditioning Regimens

  • fludarabine and busulfan +/- thymoglobulin
  • fractionated total body irradiation and cyclophosphamide
  • busulfan and cyclophosphamide
  • single dose total body irradiation and cyclophosphamide

Day -2 = GvHD prophylaxis

Day 0 or +1 = PBSC transplant

Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day

Total of all reporting groups
Overall Number of Baseline Participants 24 24 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 48 participants
53
(21 to 65)
57
(32 to 64)
56
(21 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Female
13
  54.2%
8
  33.3%
21
  43.8%
Male
11
  45.8%
16
  66.7%
27
  56.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 24 participants 48 participants
24 23 48
1.Primary Outcome
Title Number of Donors Requiring a Second Collection to Obtain a Minimum CD34/Kg (2 x 10^6) Necessary for Allogeneic Stem Cell Transplantation
Hide Description The primary endpoint is to reduce the number of donors treated with GM-CSF who require a second collection to obtain a minimum CD34/Kg (2 x 106) necessary for allogeneic stem cell transplantation when compared to historic controls mobilized with GM-CSF or plerixafor alone. A reduction in failed first leukapheresis from 40% to less than 10% as seen with G-CSF alone would be considered clinically meaningful.
Time Frame Up to 6 days
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[Not Specified]
Arm/Group Title Arm 1 - Donor
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Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)

Day 5: Mobilization with 320 mcg/kg plerixafor IV

Day 5: Leukopheresis

If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6.

Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
4
  17.4%
2.Secondary Outcome
Title Proportion of Donors Who Experience Grade 3-4 Infusion Toxicity
Hide Description Infusional toxicity will be evaluated by measuring the patient’s blood pressure, heart rate, respirations and temperature one hour prior to the allograft infusion and then 15 minutes, 30 minutes, one hour, 2 hours, and 4 hours, and 6 hours post infusion. Donors will have vital signs collected at each time point. EKGs will be performed immediately prior to IV AMD3100 and one hour after infusion.
Time Frame 30 days after completion of therapy (estimated to be 36 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor
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Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)

Day 5: Mobilization with 320 mcg/kg plerixafor IV

Day 5: Leukopheresis

If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6.

Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
2
   8.7%
3.Secondary Outcome
Title Number of Donors Who Mobilize ≥ 2x10^6 CD34+ Cells/Kg Recipient Weight Safely Following One or Two Aphereses
Hide Description -The donor will undergo a leukapheresis procedure to process 20L of blood volume. After the procedure, the collection will be analyzed to look at CD34+ cell content. If it contains at least 2x10^6 CD34+ cells/kg, then the procedure will be considered successful.
Time Frame Up to 6 days
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Donor
Hide Arm/Group Description:

Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)

Day 5: Mobilization with 320 mcg/kg plerixafor IV

Day 5: Leukopheresis

If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6.

Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
23
 100.0%
4.Secondary Outcome
Title Percentage of Donors Who Reach 5x10^6 CD34+ Cells/Kg Recipient Weight in 1 or 2 Aphereses
Hide Description -The donor will undergo a leukapheresis procedure to process 20L of blood volume. After the procedure, the collection will be analyzed to look at CD34+ cell content. The percentage of donors who reach at least 5x10^6 CD34+ cells/Kg recipient weight will be analyzed for this outcome measure.
Time Frame 6 days
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Hide Analysis Population Description
-If patients achieved ≥ 2x10^6 CD34+ cells/Kg, they were not required to go on to a second day of collection
Arm/Group Title Arm 1 - Donor
Hide Arm/Group Description:

Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)

Day 5: Mobilization with 320 mcg/kg plerixafor IV

Day 5: Leukopheresis

If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6.

Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
8
  34.8%
5.Secondary Outcome
Title Determine if Peripheral Blood Stem Cell Products Collected After Mobilization With IV Plerixafor Can be Used Safely for Hematopoietic Cell Transplantation in HLA-matched Recipients as Measured by Time to Neutrophil Engraftment (Recipient Only)
Hide Description -Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/ul following conditioning regimen induced nadir.
Time Frame Up to Day 21
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[Not Specified]
Arm/Group Title Arm 2 - Recipient
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Conditioning Regimens

  • fludarabine and busulfan +/- thymoglobulin
  • fractionated total body irradiation and cyclophosphamide
  • busulfan and cyclophosphamide
  • single dose total body irradiation and cyclophosphamide

Day -2 = GvHD prophylaxis

Day 0 or +1 = PBSC transplant

Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
20
  95.2%
6.Secondary Outcome
Title Kinetics of Immune Reconstitution as Measured by Time to Neutrophil Engraftment (Recipient Only)
Hide Description -Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/ul following conditioning regimen induced nadir.
Time Frame Up to Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 2 - Recipient
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Conditioning Regimens

  • fludarabine and busulfan +/- thymoglobulin
  • fractionated total body irradiation and cyclophosphamide
  • busulfan and cyclophosphamide
  • single dose total body irradiation and cyclophosphamide

Day -2 = GvHD prophylaxis

Day 0 or +1 = PBSC transplant

Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day

Overall Number of Participants Analyzed 21
Median (Full Range)
Unit of Measure: days
12
(11 to 22)
7.Secondary Outcome
Title Kinetics of Immune Reconstitution as Measured by Time to Platelet Engraftment (Recipient Only)
Hide Description -Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 20,000/ul without platelet transfusion support for 7 days.
Time Frame Up to Day 180
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Hide Analysis Population Description
1 recipient did not have platelet engraftment by Day 180 and is not evaluable for this outcome measure.
Arm/Group Title Arm 2 - Recipient
Hide Arm/Group Description:

Conditioning Regimens

  • fludarabine and busulfan +/- thymoglobulin
  • fractionated total body irradiation and cyclophosphamide
  • busulfan and cyclophosphamide
  • single dose total body irradiation and cyclophosphamide

Day -2 = GvHD prophylaxis

Day 0 or +1 = PBSC transplant

Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day

Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: days
22
(15 to 106)
8.Secondary Outcome
Title Rate of Acute Graft vs. Host Disease (GvHD) (Recipient Only)
Hide Description -Incidence and severity of acute GVHD will be assessed based on the Seattle criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
Time Frame Up through Day 100
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3 of the recipients received cells mobilized by 10 mcg/kg of GM-CSF and the 11 recipients received stem cells from donors mobilized with the decreased dose of 5 mcg/kg of GM-CSF.
Arm/Group Title Arm 2 - Recipient
Hide Arm/Group Description:

Conditioning Regimens

  • fludarabine and busulfan +/- thymoglobulin
  • fractionated total body irradiation and cyclophosphamide
  • busulfan and cyclophosphamide
  • single dose total body irradiation and cyclophosphamide

Day -2 = GvHD prophylaxis

Day 0 or +1 = PBSC transplant

Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
14
  66.7%
9.Secondary Outcome
Title Rate of Chronic Graft vs. Host Disease (GvHD) (Recipient Only)
Hide Description Incidence and severity of chronic GVHD will be assessed based on the NIH consensus criteria and global severity scoring system. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
Time Frame Day 100-1 year
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Hide Analysis Population Description
6 participants are not evaluable for this outcome measure as they came off study prior to the start of chronic GvHD assessments.
Arm/Group Title Arm 2 - Recipient
Hide Arm/Group Description:

Conditioning Regimens

  • fludarabine and busulfan +/- thymoglobulin
  • fractionated total body irradiation and cyclophosphamide
  • busulfan and cyclophosphamide
  • single dose total body irradiation and cyclophosphamide

Day -2 = GvHD prophylaxis

Day 0 or +1 = PBSC transplant

Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
10
  66.7%
10.Secondary Outcome
Title Transplant Related Mortality (Recipient Only)
Hide Description Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause.
Time Frame 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 2 - Recipient
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Conditioning Regimens

  • fludarabine and busulfan +/- thymoglobulin
  • fractionated total body irradiation and cyclophosphamide
  • busulfan and cyclophosphamide
  • single dose total body irradiation and cyclophosphamide

Day -2 = GvHD prophylaxis

Day 0 or +1 = PBSC transplant

Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
2
   9.5%
11.Secondary Outcome
Title Relapse and Disease Progression Rate
Hide Description -A patient will be considered relapsed (disease progressed) when there is a recurrence of the original malignant disease after transplantation.
Time Frame Up to 1 year
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[Not Specified]
Arm/Group Title Arm 2 - Recipient
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Conditioning Regimens

  • fludarabine and busulfan +/- thymoglobulin
  • fractionated total body irradiation and cyclophosphamide
  • busulfan and cyclophosphamide
  • single dose total body irradiation and cyclophosphamide

Day -2 = GvHD prophylaxis

Day 0 or +1 = PBSC transplant

Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
5
  23.8%
12.Secondary Outcome
Title Death of Any Cause (Recipients Only)
Hide Description [Not Specified]
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 2 - Recipient
Hide Arm/Group Description:

Conditioning Regimens

  • fludarabine and busulfan +/- thymoglobulin
  • fractionated total body irradiation and cyclophosphamide
  • busulfan and cyclophosphamide
  • single dose total body irradiation and cyclophosphamide

Day -2 = GvHD prophylaxis

Day 0 or +1 = PBSC transplant

Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
9
  42.9%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 - Donor Arm 2 - Recipient
Hide Arm/Group Description

Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)

Day 5: Mobilization with 320 mcg/kg plerixafor IV

Day 5: Leukopheresis

If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6.

Conditioning Regimens

  • fludarabine and busulfan +/- thymoglobulin
  • fractionated total body irradiation and cyclophosphamide
  • busulfan and cyclophosphamide
  • single dose total body irradiation and cyclophosphamide

Day -2 = GvHD prophylaxis

Day 0 or +1 = PBSC transplant

Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day

All-Cause Mortality
Arm 1 - Donor Arm 2 - Recipient
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 - Donor Arm 2 - Recipient
Affected / at Risk (%) Affected / at Risk (%)
Total   1/23 (4.35%)   8/21 (38.10%) 
Cardiac disorders     
Cardiac arrest  1  0/23 (0.00%)  1/21 (4.76%) 
Gastrointestinal disorders     
Diarrhea  1  0/23 (0.00%)  1/21 (4.76%) 
Nausea  1  0/23 (0.00%)  1/21 (4.76%) 
Vomiting  1  0/23 (0.00%)  1/21 (4.76%) 
General disorders     
Fatigue  1  0/23 (0.00%)  1/21 (4.76%) 
Rigors  1  0/23 (0.00%)  1/21 (4.76%) 
Infections and infestations     
Enterocolitis infectious  1  0/23 (0.00%)  1/21 (4.76%) 
Lung infection  1  0/23 (0.00%)  1/21 (4.76%) 
Sepsis  1  0/23 (0.00%)  2/21 (9.52%) 
Sinusitis  1  0/23 (0.00%)  1/21 (4.76%) 
Investigations     
Transamintis  1  0/23 (0.00%)  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/23 (4.35%)  0/21 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/23 (0.00%)  1/21 (4.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 - Donor Arm 2 - Recipient
Affected / at Risk (%) Affected / at Risk (%)
Total   23/23 (100.00%)   21/21 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  11/23 (47.83%)  7/21 (33.33%) 
Febrile neutropenia  1  0/23 (0.00%)  9/21 (42.86%) 
Hemolytic anemia  1  0/23 (0.00%)  1/21 (4.76%) 
Cardiac disorders     
Atrial fibrillation  1  0/23 (0.00%)  2/21 (9.52%) 
Chest pain - cardiac  1  1/23 (4.35%)  0/21 (0.00%) 
Heart failure  1  0/23 (0.00%)  1/21 (4.76%) 
Heart racing  1  0/23 (0.00%)  1/21 (4.76%) 
Palpitations  1  1/23 (4.35%)  1/21 (4.76%) 
Pericarditis  1  0/23 (0.00%)  1/21 (4.76%) 
Sinus bradycardia  1  3/23 (13.04%)  2/21 (9.52%) 
Sinus tachycardia  1  1/23 (4.35%)  2/21 (9.52%) 
Supraventricular tachycardia  1  0/23 (0.00%)  1/21 (4.76%) 
Eye disorders     
Conjunctivitis  1  1/23 (4.35%)  0/21 (0.00%) 
Visual disturbance (purple lights)  1  0/23 (0.00%)  1/21 (4.76%) 
Gastrointestinal disorders     
Abdominal distension  1  0/23 (0.00%)  2/21 (9.52%) 
Abdominal pain  1  4/23 (17.39%)  2/21 (9.52%) 
Anal pain  1  0/23 (0.00%)  1/21 (4.76%) 
Bloating  1  1/23 (4.35%)  0/21 (0.00%) 
Colitis  1  0/23 (0.00%)  1/21 (4.76%) 
Constipation  1  1/23 (4.35%)  3/21 (14.29%) 
Diarrhea  1  10/23 (43.48%)  17/21 (80.95%) 
Dyspepsia  1  1/23 (4.35%)  1/21 (4.76%) 
Dysphagia  1  0/23 (0.00%)  2/21 (9.52%) 
Esophageal pain  1  0/23 (0.00%)  1/21 (4.76%) 
Gastroesophageal reflux disease  1  1/23 (4.35%)  1/21 (4.76%) 
Gastrointestinal pain  1  0/23 (0.00%)  1/21 (4.76%) 
Hemorrhoids  1  0/23 (0.00%)  2/21 (9.52%) 
Ileus  1  0/23 (0.00%)  1/21 (4.76%) 
Mucositis oral  1  1/23 (4.35%)  14/21 (66.67%) 
Nausea  1  8/23 (34.78%)  14/21 (66.67%) 
Oral dysesthesia  1  1/23 (4.35%)  0/21 (0.00%) 
Oral pain  1  0/23 (0.00%)  1/21 (4.76%) 
Rectal pain  1  0/23 (0.00%)  1/21 (4.76%) 
Salivary duct inflammation  1  1/23 (4.35%)  0/21 (0.00%) 
Stomach pain  1  0/23 (0.00%)  1/21 (4.76%) 
Tonsilitis  1  0/23 (0.00%)  1/21 (4.76%) 
Vomiting  1  3/23 (13.04%)  4/21 (19.05%) 
General disorders     
Catheter site swelling  1  0/23 (0.00%)  1/21 (4.76%) 
Catheter site tenderness  1  0/23 (0.00%)  1/21 (4.76%) 
Chills  1  0/23 (0.00%)  4/21 (19.05%) 
Diaphoresis  1  1/23 (4.35%)  0/21 (0.00%) 
Edema face  1  0/23 (0.00%)  1/21 (4.76%) 
Edema limbs  1  0/23 (0.00%)  9/21 (42.86%) 
Facial pain  1  1/23 (4.35%)  2/21 (9.52%) 
Fatigue  1  9/23 (39.13%)  11/21 (52.38%) 
Fever  1  1/23 (4.35%)  4/21 (19.05%) 
Flu-like symptoms  1  3/23 (13.04%)  0/21 (0.00%) 
Infusion site extravasation  1  0/23 (0.00%)  1/21 (4.76%) 
Injection site reaction  1  7/23 (30.43%)  0/21 (0.00%) 
Left chest fasciculations  1  1/23 (4.35%)  0/21 (0.00%) 
Localized edema  1  1/23 (4.35%)  1/21 (4.76%) 
Non-cardiac chest pain  1  2/23 (8.70%)  4/21 (19.05%) 
Pain  1  2/23 (8.70%)  1/21 (4.76%) 
Pain at catheter placement site  1  1/23 (4.35%)  0/21 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  0/23 (0.00%)  1/21 (4.76%) 
Hepatic failure  1  0/23 (0.00%)  1/21 (4.76%) 
Immune system disorders     
Allergic reaction  1  0/23 (0.00%)  1/21 (4.76%) 
Infections and infestations     
Catheter related infection  1  0/23 (0.00%)  1/21 (4.76%) 
Enterocolitis infectious  1  0/23 (0.00%)  1/21 (4.76%) 
Gum infection  1  0/23 (0.00%)  1/21 (4.76%) 
HSV stomatitis  1  0/23 (0.00%)  1/21 (4.76%) 
Lung infection  1  0/23 (0.00%)  1/21 (4.76%) 
Nail infection  1  0/23 (0.00%)  1/21 (4.76%) 
Oral HSV  1  0/23 (0.00%)  1/21 (4.76%) 
Sepsis  1  0/23 (0.00%)  2/21 (9.52%) 
Skin infection  1  1/23 (4.35%)  2/21 (9.52%) 
Stool VRE  1  0/23 (0.00%)  1/21 (4.76%) 
Urinary tract infection  1  0/23 (0.00%)  1/21 (4.76%) 
Injury, poisoning and procedural complications     
Bruising  1  0/23 (0.00%)  1/21 (4.76%) 
Hip fracture  1  0/23 (0.00%)  1/21 (4.76%) 
Spinal fracture  1  0/23 (0.00%)  1/21 (4.76%) 
Vascular access complication  1  7/23 (30.43%)  0/21 (0.00%) 
Investigations     
Activated partial thromboplastin time prolonged  1  1/23 (4.35%)  2/21 (9.52%) 
Alanine aminotransferase increased  1  0/23 (0.00%)  6/21 (28.57%) 
Alkaline phosphatase increased  1  0/23 (0.00%)  3/21 (14.29%) 
Aspartate aminotransferase increased  1  0/23 (0.00%)  4/21 (19.05%) 
Blood bilirubin increased  1  0/23 (0.00%)  9/21 (42.86%) 
Creatinine increased  1  1/23 (4.35%)  6/21 (28.57%) 
Ejection fraction decreased  1  0/23 (0.00%)  1/21 (4.76%) 
Hypernatremia  1  0/23 (0.00%)  2/21 (9.52%) 
Hyperuricemia  1  0/23 (0.00%)  4/21 (19.05%) 
INR increased  1  1/23 (4.35%)  2/21 (9.52%) 
Lymphocyte count decreased  1  1/23 (4.35%)  2/21 (9.52%) 
Lymphocyte count increased  1  0/23 (0.00%)  2/21 (9.52%) 
Neutrophil count decreased  1  1/23 (4.35%)  8/21 (38.10%) 
Platelet count decreased  1  14/23 (60.87%)  13/21 (61.90%) 
White blood cell count decreased  1  1/23 (4.35%)  6/21 (28.57%) 
Metabolism and nutrition disorders     
Acidosis  1  0/23 (0.00%)  1/21 (4.76%) 
Anorexia  1  3/23 (13.04%)  7/21 (33.33%) 
Hyperglycemia  1  1/23 (4.35%)  2/21 (9.52%) 
Hyperkalemia  1  0/23 (0.00%)  6/21 (28.57%) 
Hypoalbuminemia  1  0/23 (0.00%)  3/21 (14.29%) 
Hypocalcemia  1  1/23 (4.35%)  4/21 (19.05%) 
Hypokalemia  1  0/23 (0.00%)  2/21 (9.52%) 
Hypomagnesemia  1  0/23 (0.00%)  5/21 (23.81%) 
Hyponatremia  1  1/23 (4.35%)  4/21 (19.05%) 
Hypophosphatemia  1  0/23 (0.00%)  2/21 (9.52%) 
Phosphate increased  1  0/23 (0.00%)  1/21 (4.76%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/23 (30.43%)  2/21 (9.52%) 
Back pain  1  9/23 (39.13%)  4/21 (19.05%) 
Bone pain  1  7/23 (30.43%)  3/21 (14.29%) 
Chest wall pain  1  5/23 (21.74%)  0/21 (0.00%) 
Dislocation Left Hip Hemiarthroplasty  1  0/23 (0.00%)  1/21 (4.76%) 
Fall  1  0/23 (0.00%)  1/21 (4.76%) 
Flank pain  1  1/23 (4.35%)  0/21 (0.00%) 
Generalized muscle weakness  1  1/23 (4.35%)  1/21 (4.76%) 
Myalgia  1  2/23 (8.70%)  0/21 (0.00%) 
Neck pain  1  1/23 (4.35%)  1/21 (4.76%) 
Pain in extremity  1  6/23 (26.09%)  5/21 (23.81%) 
Nervous system disorders     
Cognitive disturbance  1  0/23 (0.00%)  1/21 (4.76%) 
Dizziness  1  7/23 (30.43%)  3/21 (14.29%) 
Headache  1  9/23 (39.13%)  10/21 (47.62%) 
Hypersomnia  1  0/23 (0.00%)  1/21 (4.76%) 
Paresthesia  1  4/23 (17.39%)  0/21 (0.00%) 
Peripheral sensory neuropathy  1  3/23 (13.04%)  1/21 (4.76%) 
Presyncope  1  4/23 (17.39%)  0/21 (0.00%) 
Seizure  1  0/23 (0.00%)  1/21 (4.76%) 
Somnolence  1  0/23 (0.00%)  2/21 (9.52%) 
Tremor  1  0/23 (0.00%)  1/21 (4.76%) 
Psychiatric disorders     
Anxiety  1  5/23 (21.74%)  1/21 (4.76%) 
Confusion  1  0/23 (0.00%)  2/21 (9.52%) 
Depression  1  1/23 (4.35%)  1/21 (4.76%) 
Excessive dreams  1  0/23 (0.00%)  1/21 (4.76%) 
Insomnia  1  0/23 (0.00%)  2/21 (9.52%) 
Renal and urinary disorders     
Acute kidney injury  1  0/23 (0.00%)  3/21 (14.29%) 
Renal colic  1  1/23 (4.35%)  0/21 (0.00%) 
Urinary tract pain  1  1/23 (4.35%)  0/21 (0.00%) 
Urinary tract pain  1  0/23 (0.00%)  2/21 (9.52%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  1/23 (4.35%)  1/21 (4.76%) 
Aspiration  1  0/23 (0.00%)  1/21 (4.76%) 
Atelectasis  1  0/23 (0.00%)  1/21 (4.76%) 
Cough  1  2/23 (8.70%)  3/21 (14.29%) 
Dyspnea  1  1/23 (4.35%)  4/21 (19.05%) 
Epistaxis  1  0/23 (0.00%)  2/21 (9.52%) 
Hiccups  1  0/23 (0.00%)  2/21 (9.52%) 
Hypoxia  1  0/23 (0.00%)  3/21 (14.29%) 
Laryngeal inflammation  1  0/23 (0.00%)  1/21 (4.76%) 
Nasal congestion  1  2/23 (8.70%)  0/21 (0.00%) 
Pleural effusion  1  0/23 (0.00%)  1/21 (4.76%) 
Pleuritic pain  1  0/23 (0.00%)  1/21 (4.76%) 
Pulmonary edema  1  0/23 (0.00%)  1/21 (4.76%) 
Sore throat  1  3/23 (13.04%)  5/21 (23.81%) 
Skin and subcutaneous tissue disorders     
GVHD - Skin (Rash)  1  0/23 (0.00%)  1/21 (4.76%) 
Hypohidrosis  1  0/23 (0.00%)  1/21 (4.76%) 
Jaundice  1  0/23 (0.00%)  1/21 (4.76%) 
Pruritus  1  0/23 (0.00%)  3/21 (14.29%) 
Rash - GVHD (Chest)  1  0/23 (0.00%)  1/21 (4.76%) 
Rash - GVHD (Palms)  1  0/23 (0.00%)  1/21 (4.76%) 
Rash - GVHD (Skin in general)  1  0/23 (0.00%)  1/21 (4.76%) 
Rash maculo-papular  1  0/23 (0.00%)  7/21 (33.33%) 
Skin ulceration  1  0/23 (0.00%)  3/21 (14.29%) 
Vascular disorders     
Flushing  1  1/23 (4.35%)  1/21 (4.76%) 
Hot flashes  1  1/23 (4.35%)  0/21 (0.00%) 
Hypertension  1  1/23 (4.35%)  5/21 (23.81%) 
Hypotension  1  5/23 (21.74%)  2/21 (9.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark Schroeder, M.D.
Organization: Washington University School of Medicine
Phone: 314-454-8304
EMail: markschroeder@wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01158118     History of Changes
Other Study ID Numbers: 10-1154 / 201108083
First Submitted: July 6, 2010
First Posted: July 8, 2010
Results First Submitted: March 22, 2017
Results First Posted: May 3, 2017
Last Update Posted: June 5, 2017