Trial Outcomes & Findings for Plerixafor and Sargramostim (GM-CSF) for Mobilization of Allogeneic Sibling Donors (NCT NCT01158118)
NCT ID: NCT01158118
Last Updated: 2017-06-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Up to 6 days
Results posted on
2017-06-05
Participant Flow
Participant milestones
| Measure |
Arm 1 - Donor
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.
|
Arm 2 - Recipient
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 Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Arm 1 - Donor
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.
|
Arm 2 - Recipient
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 Study
Screen failure
|
1
|
0
|
|
Overall Study
Donor match was a screen failure
|
0
|
1
|
|
Overall Study
Suffered stroke prior to transplant
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Plerixafor and Sargramostim (GM-CSF) for Mobilization of Allogeneic Sibling Donors
Baseline characteristics by cohort
| Measure |
Arm 1 - Donor
n=24 Participants
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.
|
Arm 2 - Recipient
n=24 Participants
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
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
57 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 daysThe 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.
Outcome measures
| Measure |
Arm 1 - Donor
n=23 Participants
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.
|
|---|---|
|
Number of Donors Requiring a Second Collection to Obtain a Minimum CD34/Kg (2 x 10^6) Necessary for Allogeneic Stem Cell Transplantation
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 days after completion of therapy (estimated to be 36 days)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.
Outcome measures
| Measure |
Arm 1 - Donor
n=23 Participants
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.
|
|---|---|
|
Proportion of Donors Who Experience Grade 3-4 Infusion Toxicity
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 6 days-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.
Outcome measures
| Measure |
Arm 1 - Donor
n=23 Participants
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.
|
|---|---|
|
Number of Donors Who Mobilize ≥ 2x10^6 CD34+ Cells/Kg Recipient Weight Safely Following One or Two Aphereses
|
23 Participants
|
SECONDARY outcome
Timeframe: 6 daysPopulation: -If patients achieved ≥ 2x10\^6 CD34+ cells/Kg, they were not required to go on to a second day of collection
-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.
Outcome measures
| Measure |
Arm 1 - Donor
n=23 Participants
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.
|
|---|---|
|
Percentage of Donors Who Reach 5x10^6 CD34+ Cells/Kg Recipient Weight in 1 or 2 Aphereses
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to Day 21-Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/ul following conditioning regimen induced nadir.
Outcome measures
| Measure |
Arm 1 - Donor
n=21 Participants
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.
|
|---|---|
|
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)
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to Day 100-Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/ul following conditioning regimen induced nadir.
Outcome measures
| Measure |
Arm 1 - Donor
n=21 Participants
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.
|
|---|---|
|
Kinetics of Immune Reconstitution as Measured by Time to Neutrophil Engraftment (Recipient Only)
|
12 days
Interval 11.0 to 22.0
|
SECONDARY outcome
Timeframe: Up to Day 180Population: 1 recipient did not have platelet engraftment by Day 180 and is not evaluable for this outcome measure.
-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.
Outcome measures
| Measure |
Arm 1 - Donor
n=20 Participants
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.
|
|---|---|
|
Kinetics of Immune Reconstitution as Measured by Time to Platelet Engraftment (Recipient Only)
|
22 days
Interval 15.0 to 106.0
|
SECONDARY outcome
Timeframe: Up through Day 100Population: 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.
-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).
Outcome measures
| Measure |
Arm 1 - Donor
n=21 Participants
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.
|
|---|---|
|
Rate of Acute Graft vs. Host Disease (GvHD) (Recipient Only)
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 100-1 yearPopulation: 6 participants are not evaluable for this outcome measure as they came off study prior to the start of chronic GvHD assessments.
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).
Outcome measures
| Measure |
Arm 1 - Donor
n=15 Participants
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.
|
|---|---|
|
Rate of Chronic Graft vs. Host Disease (GvHD) (Recipient Only)
|
10 Participants
|
SECONDARY outcome
Timeframe: 100 daysDeath 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.
Outcome measures
| Measure |
Arm 1 - Donor
n=21 Participants
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.
|
|---|---|
|
Transplant Related Mortality (Recipient Only)
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 1 year-A patient will be considered relapsed (disease progressed) when there is a recurrence of the original malignant disease after transplantation.
Outcome measures
| Measure |
Arm 1 - Donor
n=21 Participants
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.
|
|---|---|
|
Relapse and Disease Progression Rate
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearOutcome measures
| Measure |
Arm 1 - Donor
n=21 Participants
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.
|
|---|---|
|
Death of Any Cause (Recipients Only)
|
9 Participants
|
Adverse Events
Arm 1 - Donor
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm 2 - Recipient
Serious events: 8 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 - Donor
n=23 participants at risk
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.
|
Arm 2 - Recipient
n=21 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/23
|
4.8%
1/21
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/23
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
1/23
|
0.00%
0/21
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/23
|
4.8%
1/21
|
|
General disorders
Fatigue
|
0.00%
0/23
|
4.8%
1/21
|
|
Infections and infestations
Lung infection
|
0.00%
0/23
|
4.8%
1/21
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23
|
4.8%
1/21
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/23
|
4.8%
1/21
|
|
General disorders
Rigors
|
0.00%
0/23
|
4.8%
1/21
|
|
Infections and infestations
Sepsis
|
0.00%
0/23
|
9.5%
2/21
|
|
Infections and infestations
Sinusitis
|
0.00%
0/23
|
4.8%
1/21
|
|
Investigations
Transamintis
|
0.00%
0/23
|
4.8%
1/21
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23
|
4.8%
1/21
|
Other adverse events
| Measure |
Arm 1 - Donor
n=23 participants at risk
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.
|
Arm 2 - Recipient
n=21 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/23
|
9.5%
2/21
|
|
Gastrointestinal disorders
Abdominal pain
|
17.4%
4/23
|
9.5%
2/21
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/23
|
4.8%
1/21
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.3%
1/23
|
9.5%
2/21
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/23
|
14.3%
3/21
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/23
|
28.6%
6/21
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/23
|
14.3%
3/21
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/23
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.3%
1/23
|
4.8%
1/21
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/23
|
4.8%
1/21
|
|
Blood and lymphatic system disorders
Anemia
|
47.8%
11/23
|
33.3%
7/21
|
|
Metabolism and nutrition disorders
Anorexia
|
13.0%
3/23
|
33.3%
7/21
|
|
Psychiatric disorders
Anxiety
|
21.7%
5/23
|
4.8%
1/21
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.4%
7/23
|
9.5%
2/21
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/23
|
19.0%
4/21
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/23
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/23
|
4.8%
1/21
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/23
|
9.5%
2/21
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
39.1%
9/23
|
19.0%
4/21
|
|
Gastrointestinal disorders
Bloating
|
4.3%
1/23
|
0.00%
0/21
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/23
|
42.9%
9/21
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
30.4%
7/23
|
14.3%
3/21
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/23
|
4.8%
1/21
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/23
|
4.8%
1/21
|
|
General disorders
Catheter site swelling
|
0.00%
0/23
|
4.8%
1/21
|
|
General disorders
Catheter site tenderness
|
0.00%
0/23
|
4.8%
1/21
|
|
Cardiac disorders
Chest pain - cardiac
|
4.3%
1/23
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
21.7%
5/23
|
0.00%
0/21
|
|
General disorders
Chills
|
0.00%
0/23
|
19.0%
4/21
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/23
|
4.8%
1/21
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/23
|
4.8%
1/21
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/23
|
4.8%
1/21
|
|
Psychiatric disorders
Confusion
|
0.00%
0/23
|
9.5%
2/21
|
|
Eye disorders
Conjunctivitis
|
4.3%
1/23
|
0.00%
0/21
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23
|
14.3%
3/21
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
2/23
|
14.3%
3/21
|
|
Investigations
Creatinine increased
|
4.3%
1/23
|
28.6%
6/21
|
|
Psychiatric disorders
Depression
|
4.3%
1/23
|
4.8%
1/21
|
|
General disorders
Diaphoresis
|
4.3%
1/23
|
0.00%
0/21
|
|
Gastrointestinal disorders
Diarrhea
|
43.5%
10/23
|
81.0%
17/21
|
|
Musculoskeletal and connective tissue disorders
Dislocation Left Hip Hemiarthroplasty
|
0.00%
0/23
|
4.8%
1/21
|
|
Nervous system disorders
Dizziness
|
30.4%
7/23
|
14.3%
3/21
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23
|
4.8%
1/21
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/23
|
9.5%
2/21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
1/23
|
19.0%
4/21
|
|
General disorders
Edema face
|
0.00%
0/23
|
4.8%
1/21
|
|
General disorders
Edema limbs
|
0.00%
0/23
|
42.9%
9/21
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/23
|
4.8%
1/21
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/23
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/23
|
9.5%
2/21
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/23
|
4.8%
1/21
|
|
Psychiatric disorders
Excessive dreams
|
0.00%
0/23
|
4.8%
1/21
|
|
General disorders
Facial pain
|
4.3%
1/23
|
9.5%
2/21
|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.00%
0/23
|
4.8%
1/21
|
|
General disorders
Fatigue
|
39.1%
9/23
|
52.4%
11/21
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/23
|
42.9%
9/21
|
|
General disorders
Fever
|
4.3%
1/23
|
19.0%
4/21
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.3%
1/23
|
0.00%
0/21
|
|
General disorders
Flu-like symptoms
|
13.0%
3/23
|
0.00%
0/21
|
|
Vascular disorders
Flushing
|
4.3%
1/23
|
4.8%
1/21
|
|
Skin and subcutaneous tissue disorders
GVHD - Skin (Rash)
|
0.00%
0/23
|
4.8%
1/21
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.3%
1/23
|
4.8%
1/21
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/23
|
4.8%
1/21
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.3%
1/23
|
4.8%
1/21
|
|
Infections and infestations
Gum infection
|
0.00%
0/23
|
4.8%
1/21
|
|
Infections and infestations
HSV stomatitis
|
0.00%
0/23
|
4.8%
1/21
|
|
Nervous system disorders
Headache
|
39.1%
9/23
|
47.6%
10/21
|
|
Cardiac disorders
Heart failure
|
0.00%
0/23
|
4.8%
1/21
|
|
Cardiac disorders
Heart racing
|
0.00%
0/23
|
4.8%
1/21
|
|
Blood and lymphatic system disorders
Hemolytic anemia
|
0.00%
0/23
|
4.8%
1/21
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/23
|
9.5%
2/21
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/23
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/23
|
9.5%
2/21
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/23
|
4.8%
1/21
|
|
Vascular disorders
Hot flashes
|
4.3%
1/23
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.3%
1/23
|
9.5%
2/21
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/23
|
28.6%
6/21
|
|
Investigations
Hypernatremia
|
0.00%
0/23
|
9.5%
2/21
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/23
|
4.8%
1/21
|
|
Vascular disorders
Hypertension
|
4.3%
1/23
|
23.8%
5/21
|
|
Investigations
Hyperuricemia
|
0.00%
0/23
|
19.0%
4/21
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/23
|
14.3%
3/21
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.3%
1/23
|
19.0%
4/21
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
0.00%
0/23
|
4.8%
1/21
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/23
|
9.5%
2/21
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/23
|
23.8%
5/21
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.3%
1/23
|
19.0%
4/21
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/23
|
9.5%
2/21
|
|
Vascular disorders
Hypotension
|
21.7%
5/23
|
9.5%
2/21
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/23
|
14.3%
3/21
|
|
Investigations
INR increased
|
4.3%
1/23
|
9.5%
2/21
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/23
|
4.8%
1/21
|
|
General disorders
Infusion site extravasation
|
0.00%
0/23
|
4.8%
1/21
|
|
General disorders
Injection site reaction
|
30.4%
7/23
|
0.00%
0/21
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/23
|
9.5%
2/21
|
|
Skin and subcutaneous tissue disorders
Jaundice
|
0.00%
0/23
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/23
|
4.8%
1/21
|
|
General disorders
Left chest fasciculations
|
4.3%
1/23
|
0.00%
0/21
|
|
General disorders
Localized edema
|
4.3%
1/23
|
4.8%
1/21
|
|
Infections and infestations
Lung infection
|
0.00%
0/23
|
4.8%
1/21
|
|
Investigations
Lymphocyte count decreased
|
4.3%
1/23
|
9.5%
2/21
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/23
|
9.5%
2/21
|
|
Gastrointestinal disorders
Mucositis oral
|
4.3%
1/23
|
66.7%
14/21
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
2/23
|
0.00%
0/21
|
|
Infections and infestations
Nail infection
|
0.00%
0/23
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.7%
2/23
|
0.00%
0/21
|
|
Gastrointestinal disorders
Nausea
|
34.8%
8/23
|
66.7%
14/21
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
1/23
|
4.8%
1/21
|
|
Investigations
Neutrophil count decreased
|
4.3%
1/23
|
38.1%
8/21
|
|
General disorders
Non-cardiac chest pain
|
8.7%
2/23
|
19.0%
4/21
|
|
Infections and infestations
Oral HSV
|
0.00%
0/23
|
4.8%
1/21
|
|
Gastrointestinal disorders
Oral dysesthesia
|
4.3%
1/23
|
0.00%
0/21
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/23
|
4.8%
1/21
|
|
General disorders
Pain
|
8.7%
2/23
|
4.8%
1/21
|
|
General disorders
Pain at catheter placement site
|
4.3%
1/23
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.1%
6/23
|
23.8%
5/21
|
|
Cardiac disorders
Palpitations
|
4.3%
1/23
|
4.8%
1/21
|
|
Nervous system disorders
Paresthesia
|
17.4%
4/23
|
0.00%
0/21
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/23
|
4.8%
1/21
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.0%
3/23
|
4.8%
1/21
|
|
Metabolism and nutrition disorders
Phosphate increased
|
0.00%
0/23
|
4.8%
1/21
|
|
Investigations
Platelet count decreased
|
60.9%
14/23
|
61.9%
13/21
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/23
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/23
|
4.8%
1/21
|
|
Nervous system disorders
Presyncope
|
17.4%
4/23
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/23
|
14.3%
3/21
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/23
|
4.8%
1/21
|
|
Skin and subcutaneous tissue disorders
Rash - GVHD (Chest)
|
0.00%
0/23
|
4.8%
1/21
|
|
Skin and subcutaneous tissue disorders
Rash - GVHD (Palms)
|
0.00%
0/23
|
4.8%
1/21
|
|
Skin and subcutaneous tissue disorders
Rash - GVHD (Skin in general)
|
0.00%
0/23
|
4.8%
1/21
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/23
|
33.3%
7/21
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/23
|
4.8%
1/21
|
|
Renal and urinary disorders
Renal colic
|
4.3%
1/23
|
0.00%
0/21
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
4.3%
1/23
|
0.00%
0/21
|
|
Nervous system disorders
Seizure
|
0.00%
0/23
|
4.8%
1/21
|
|
Infections and infestations
Sepsis
|
0.00%
0/23
|
9.5%
2/21
|
|
Cardiac disorders
Sinus bradycardia
|
13.0%
3/23
|
9.5%
2/21
|
|
Cardiac disorders
Sinus tachycardia
|
4.3%
1/23
|
9.5%
2/21
|
|
Infections and infestations
Skin infection
|
4.3%
1/23
|
9.5%
2/21
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/23
|
14.3%
3/21
|
|
Nervous system disorders
Somnolence
|
0.00%
0/23
|
9.5%
2/21
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
13.0%
3/23
|
23.8%
5/21
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/23
|
4.8%
1/21
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/23
|
4.8%
1/21
|
|
Infections and infestations
Stool VRE
|
0.00%
0/23
|
4.8%
1/21
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/23
|
4.8%
1/21
|
|
Gastrointestinal disorders
Tonsilitis
|
0.00%
0/23
|
4.8%
1/21
|
|
Nervous system disorders
Tremor
|
0.00%
0/23
|
4.8%
1/21
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23
|
4.8%
1/21
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/23
|
9.5%
2/21
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
30.4%
7/23
|
0.00%
0/21
|
|
Eye disorders
Visual disturbance (purple lights)
|
0.00%
0/23
|
4.8%
1/21
|
|
Gastrointestinal disorders
Vomiting
|
13.0%
3/23
|
19.0%
4/21
|
|
Investigations
White blood cell count decreased
|
4.3%
1/23
|
28.6%
6/21
|
Additional Information
Mark Schroeder, M.D.
Washington University School of Medicine
Phone: 314-454-8304
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place