Trial Outcomes & Findings for Donor Enhancement With Plerixafor Post Myeloablative Allogeneic Transplant (NCT NCT01280955)
NCT ID: NCT01280955
Last Updated: 2017-04-25
Results Overview
leukocytes \> 500/ul on 2 consecutive days
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
41 participants
Primary outcome timeframe
100 Days post Transplant
Results posted on
2017-04-25
Participant Flow
Patients who are appropriate candidates for myeloablative allogeneic stem cell transplantation from an HLA-matched sibling, matched unrelated donor or umbilical cord blood are eligible for enrollment. The first subject was consented on 9/28/2011. The study closed to accrual on 5/27/2014.
41 participants signed consent and 30 received transplant. 11 patients who signed consent were screen failures. Reasons patients did not receive transplant included lack of donor, insurance denial, too much disease, uncontrolled infection, class III or IV angina. 29 participants were used in results analysis because one participant withdrew.
Participant milestones
| Measure |
Transplant Recipients
This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Transplant Recipients
This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Donor Enhancement With Plerixafor Post Myeloablative Allogeneic Transplant
Baseline characteristics by cohort
| Measure |
Transplant Recipients
n=29 Participants
This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 Days post TransplantPopulation: Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed
leukocytes \> 500/ul on 2 consecutive days
Outcome measures
| Measure |
Transplant Recipients
n=29 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
Time to Neutrophil Recovery
|
17 days
Interval 16.0 to 18.0
|
PRIMARY outcome
Timeframe: 100 Days Post TransplantPopulation: Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed
platelet \> 20,000/ul on 2 consecutive days
Outcome measures
| Measure |
Transplant Recipients
n=29 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
Time to Platelet Recovery
|
18 days
Interval 15.0 to 22.0
|
PRIMARY outcome
Timeframe: 100 Days Post TransplantPopulation: Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed
Outcome measures
| Measure |
Transplant Recipients
n=29 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
Plerixafor-associated Adverse Events
GI upset
|
1 number of adverse events
|
|
Plerixafor-associated Adverse Events
nausea
|
1 number of adverse events
|
|
Plerixafor-associated Adverse Events
diarrhea
|
2 number of adverse events
|
|
Plerixafor-associated Adverse Events
fatigue
|
1 number of adverse events
|
|
Plerixafor-associated Adverse Events
rash
|
1 number of adverse events
|
|
Plerixafor-associated Adverse Events
pneumonia
|
3 number of adverse events
|
|
Plerixafor-associated Adverse Events
bruising
|
1 number of adverse events
|
SECONDARY outcome
Timeframe: 100 Days Post TransplantPopulation: Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed
Outcome measures
| Measure |
Transplant Recipients
n=29 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
Transplant-related Mortality
|
11 participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: the population includes all participants for which we have data at day 90
Cell reconstitution - absolute lymphocyte count at day 90 post transplant.
Outcome measures
| Measure |
Transplant Recipients
n=11 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
Absolute Lymphocyte Count at Day 90
|
549 number of lymphocytes
Interval 209.0 to 2219.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: the population includes all participants for which we have data at day 30
IL-12 at day 30; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation.
Outcome measures
| Measure |
Transplant Recipients
n=26 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
IL-12 at Day 30
|
40.7 pg/mL
Interval 3.9 to 211.6
|
SECONDARY outcome
Timeframe: 100 daysWe are reporting on the number of participants experiencing a grade II-IV acute graft versus host disease will be assessed weekly through Day 100 post transplant. Staging and grading of Acute GvHD is graded by pattern of organ involvement and clinical performance status using the Grading Index of Acute GvHD (Gluckman) and the Grading Index of Acute GVHD by the CIBMTR (Centers for International Blood and Marrow Transplant Research)
Outcome measures
| Measure |
Transplant Recipients
n=29 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
Participants Experiencing Grade II-IV Acute Graft Versus Host Disease
Grade 2
|
5 participants
|
|
Participants Experiencing Grade II-IV Acute Graft Versus Host Disease
Grade 3
|
5 participants
|
SECONDARY outcome
Timeframe: 90 DaysPopulation: the population includes all participants for which we have data at day 90
Cell reconstitution - CD3+ cell count at day 90 post transplant. This is a marker for the function of your immune system.
Outcome measures
| Measure |
Transplant Recipients
n=11 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
CD3+ Cell Count at Day 90
|
655 number of CD3+ cells
Interval 128.0 to 1656.0
|
SECONDARY outcome
Timeframe: 90 daysPopulation: The population includes subjects for which we have data at day 90.
CD4 cell count at Day 90; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells.
Outcome measures
| Measure |
Transplant Recipients
n=11 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
CD4 Cell Count at Day 90
|
180 number of CD4 cells
Interval 59.0 to 596.0
|
SECONDARY outcome
Timeframe: 90 daysPopulation: the population includes subjects for which we have data at day 90
CD8 cell count at Day 90; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR).
Outcome measures
| Measure |
Transplant Recipients
n=11 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
CD8 Cell Count at Day 90
|
172 number of CD8 cells
Interval 31.0 to 1209.0
|
SECONDARY outcome
Timeframe: 90 daysPopulation: the population includes subjects for which we have data at Day 90.
NK cell count at Day 90;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system.
Outcome measures
| Measure |
Transplant Recipients
n=11 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
NK Cell Count at Day 90
|
137 number of NK cells
Interval 42.0 to 495.0
|
SECONDARY outcome
Timeframe: 90 daysPopulation: the population includes subjects for which we have data at Day 90.
B cell count at Day 90; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system.
Outcome measures
| Measure |
Transplant Recipients
n=11 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
B Cell Count at Day 90
|
7 number of B cells
Interval 0.0 to 128.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: the population includes subject for which we have data at Day 30.
IFN gamma at day 30; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection.
Outcome measures
| Measure |
Transplant Recipients
n=26 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
IFN Gamma at Day 30
|
8.6 pg/mL
Interval 0.0 to 80.7
|
SECONDARY outcome
Timeframe: 30 daysPopulation: the population includes subject for which we have data at Day 30.
TNF-alpha at day 30; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells.
Outcome measures
| Measure |
Transplant Recipients
n=26 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
TNF-alpha at Day 30
|
146.5 pg/mL
Interval 0.0 to 551.6
|
SECONDARY outcome
Timeframe: 30 daysPopulation: The population includes subjects for which we have data at day 30.
CD4 cell count at Day 30; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells.
Outcome measures
| Measure |
Transplant Recipients
n=13 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
CD4 Cell Count at Day 30
|
252 number of CD4 cells
Interval 75.0 to 552.0
|
SECONDARY outcome
Timeframe: 60 daysPopulation: The population includes subjects for which we have data at day 30.
CD4 cell count at Day 60; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells.
Outcome measures
| Measure |
Transplant Recipients
n=6 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
CD4 Cell Count at Day 60
|
220 number of CD4 cells
Interval 67.0 to 317.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: the population includes subjects for which we have data at day 30
CD8 cell count at Day 30; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR).
Outcome measures
| Measure |
Transplant Recipients
n=13 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
CD8 Cell Count at Day 30
|
255 number of CD8 cells
Interval 15.0 to 1766.0
|
SECONDARY outcome
Timeframe: 60 daysPopulation: the population includes subjects for which we have data at day 60
CD8 cell count at Day 60; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR).
Outcome measures
| Measure |
Transplant Recipients
n=6 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
CD8 Cell Count at Day 60
|
199 number of CD8 cells
Interval 92.0 to 609.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: the population includes subjects for which we have data at Day 30.
NK cell count at Day 30;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system.
Outcome measures
| Measure |
Transplant Recipients
n=13 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
NK Cell Count at Day 30
|
226 number of NK cells
Interval 22.0 to 376.0
|
SECONDARY outcome
Timeframe: 60 daysPopulation: the population includes subjects for which we have data at Day 60.
NK cell count at Day 60;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system.
Outcome measures
| Measure |
Transplant Recipients
n=6 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
NK Cell Count at Day 60
|
221 number of NK cells
Interval 33.0 to 315.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: the population includes subjects for which we have data at Day 30.
B cell count at Day 30; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system.
Outcome measures
| Measure |
Transplant Recipients
n=13 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
B Cell Count at Day 30
|
6 number of B cells
Interval 1.0 to 42.0
|
SECONDARY outcome
Timeframe: 60 daysPopulation: the population includes subjects for which we have data at Day 60.
B cell count at Day 60; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system.
Outcome measures
| Measure |
Transplant Recipients
n=6 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
B Cell Count at Day 60
|
18 number of B cells
Interval 0.0 to 158.0
|
SECONDARY outcome
Timeframe: 7 daysPopulation: the population includes all participants for which we have data at day 7
IL-12 at day 7; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation.
Outcome measures
| Measure |
Transplant Recipients
n=28 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
IL-12 at Day 7
|
8.4 pg/mL
Interval 2.4 to 90.0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: the population includes all participants for which we have data at day 14
IL-12 at day 14; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation.
Outcome measures
| Measure |
Transplant Recipients
n=27 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
IL-12 at Day 14
|
13.3 pg/mL
Interval 0.9 to 222.1
|
SECONDARY outcome
Timeframe: 7 daysPopulation: the population includes subject for which we have data at Day 7.
IFN gamma at day 7; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection.
Outcome measures
| Measure |
Transplant Recipients
n=28 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
IFN Gamma at Day 7
|
3.9 pg/mL
Interval 0.0 to 116.3
|
SECONDARY outcome
Timeframe: 14 daysPopulation: the population includes subject for which we have data at Day 14.
IFN gamma at day 14; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection.
Outcome measures
| Measure |
Transplant Recipients
n=27 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
IFN Gamma at Day 14
|
20.0 pg/mL
Interval 0.0 to 243.5
|
SECONDARY outcome
Timeframe: 7 daysPopulation: the population includes subject for which we have data at Day 7.
TNF-alpha at day 7; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells.
Outcome measures
| Measure |
Transplant Recipients
n=28 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
TNF-alpha at Day 7
|
15.9 pg/mL
Interval 0.0 to 162.6
|
SECONDARY outcome
Timeframe: 14 daysPopulation: the population includes subject for which we have data at Day 14.
TNF-alpha at day 14; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells.
Outcome measures
| Measure |
Transplant Recipients
n=27 Participants
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
|
|---|---|
|
TNF-alpha at Day 14
|
43.8 pg/mL
Interval 0.9 to 190.6
|
Adverse Events
Transplant Recipients
Serious events: 12 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Transplant Recipients
n=29 participants at risk
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
Adverse Events were monitored for 29 transplant recipients
|
|---|---|
|
Infections and infestations
encephalitis
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
General disorders
death
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Infections and infestations
pneumonia
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Infections and infestations
small bowel (NOS)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
Other adverse events
| Measure |
Transplant Recipients
n=29 participants at risk
This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
Adverse Events were monitored for 29 transplant recipients
|
|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
10.3%
3/29 • Number of events 4 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Immune system disorders
hypogammagloulinemia
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Gastrointestinal disorders
Anorexia
|
17.2%
5/29 • Number of events 7 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Nervous system disorders
presbyacusis (Hearing loss)
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Renal and urinary disorders
Bladder spasms
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Blood and lymphatic system disorders
engraftment syndrome
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Blood and lymphatic system disorders
anemia
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Blood and lymphatic system disorders
pancytopenia
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Blood and lymphatic system disorders
neutropenia
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Blood and lymphatic system disorders
relapsed disease
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
13.8%
4/29 • Number of events 4 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Cardiac disorders
tacycardia
|
24.1%
7/29 • Number of events 9 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Nervous system disorders
Confusion
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Gastrointestinal disorders
Constipation
|
13.8%
4/29 • Number of events 4 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
General disorders
pyrexia (fever)
|
20.7%
6/29 • Number of events 6 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
General disorders
fatigue
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
General disorders
frail appearance
|
3.4%
1/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
General disorders
hyperthermia (overheating)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
4/29 • Number of events 4 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Metabolism and nutrition disorders
Creatinine
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Gastrointestinal disorders
Dehydration
|
10.3%
3/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
General disorders
Dental: caries
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
contact dermatitis
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
groin irratation
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
pallor
|
3.4%
1/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
erythema
|
3.4%
1/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
scratch marks
|
3.4%
1/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
purpuric lesion
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
perianal lesion
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Gastrointestinal disorders
Diarrhea
|
55.2%
16/29 • Number of events 24 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Nervous system disorders
Dizziness
|
10.3%
3/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Eye disorders
keratoconjunctivitis (Dry Eye Syndrome)
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
General disorders
Dry mouth / salivary gland (xerostomia)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
xeroderma (Dry Skin)
|
13.8%
4/29 • Number of events 4 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
13.8%
4/29 • Number of events 5 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Blood and lymphatic system disorders
Edema
|
44.8%
13/29 • Number of events 18 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower (gait / walking)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
31.0%
9/29 • Number of events 11 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Infections and infestations
Febrile neutropenia
|
20.7%
6/29 • Number of events 8 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
17.2%
5/29 • Number of events 7 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Gastrointestinal disorders
odynophagia
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Gastrointestinal disorders
oropharyngeal erythema
|
24.1%
7/29 • Number of events 13 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
General disorders
pain - general body ache
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
Hair Loss / Alopecia (scalp or body)
|
13.8%
4/29 • Number of events 4 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Ear and labyrinth disorders
Hearing Loss
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Gastrointestinal disorders
Heartburn / dyspepsia
|
10.3%
3/29 • Number of events 4 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary / upper respiratory
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Hepatobiliary disorders
hyperbilirubinemia
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
10.3%
3/29 • Number of events 5 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Cardiac disorders
Hypertension
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Cardiac disorders
Hypotension
|
17.2%
5/29 • Number of events 5 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.9%
2/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
31.0%
9/29 • Number of events 10 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Infections and infestations
viremia
|
34.5%
10/29 • Number of events 13 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Infections and infestations
rsv pneumonia
|
13.8%
4/29 • Number of events 4 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Infections and infestations
Infection with unknown ANC - Blood
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Infections and infestations
Infection with unknown ANC - Sinus
|
6.9%
2/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Infections and infestations
Infection with unknown ANC - Skin (cellulitis)
|
6.9%
2/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Infections and infestations
Infection without febrile neutropenia
|
3.4%
1/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
General disorders
Insomnia
|
17.2%
5/29 • Number of events 5 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
20.7%
6/29 • Number of events 6 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Nervous system disorders
Mental status decrease
|
10.3%
3/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
13.8%
4/29 • Number of events 4 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Nervous system disorders
pain - headache
|
10.3%
3/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Gastrointestinal disorders
Mucositis / Stomatitis (clinical exam)
|
96.6%
28/29 • Number of events 34 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
13.8%
4/29 • Number of events 5 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Musculoskeletal and connective tissue disorders
asthenia
|
20.7%
6/29 • Number of events 10 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal / Soft Tissue injury
|
13.8%
4/29 • Number of events 6 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity / paranasal sinus reactions
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Respiratory, thoracic and mediastinal disorders
Nausea
|
51.7%
15/29 • Number of events 25 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Nervous system disorders
Neurology
|
3.4%
1/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Nervous system disorders
fall
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Nervous system disorders
lethargy
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Nervous system disorders
peripheral neuropathy
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Blood and lymphatic system disorders
Neutrophils / granulocytes (ANC / AGC)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Eye disorders
subconjunctivial hemorrhage
|
3.4%
1/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Eye disorders
rheum (crusty eye)
|
6.9%
2/29 • Number of events 4 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Ear and labyrinth disorders
Otitis, middle ear (non-infectious)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
27.6%
8/29 • Number of events 10 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
13.8%
4/29 • Number of events 5 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Cardiac disorders
Pain - Chest / thorax NOS
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
6.9%
2/29 • Number of events 4 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Nervous system disorders
Pain - Head / headache
|
20.7%
6/29 • Number of events 9 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Musculoskeletal and connective tissue disorders
Pain- groin
|
17.2%
5/29 • Number of events 8 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Reproductive system and breast disorders
Pain - Ovulatory
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat / pharynx / larynx
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Blood and lymphatic system disorders
platelets
|
10.3%
3/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
3.4%
1/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis / pulmonary infiltrates
|
10.3%
3/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Musculoskeletal and connective tissue disorders
Potassium, serum-low (hypokalemia)
|
10.3%
3/29 • Number of events 6 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
Pruritus / itching
|
6.9%
2/29 • Number of events 4 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary / Upper Respiratory infiltrates
|
34.5%
10/29 • Number of events 12 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
Rash / desquamation
|
44.8%
13/29 • Number of events 19 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Skin and subcutaneous tissue disorders
Rash: acne / acneiform
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Renal and urinary disorders
hematuria
|
27.6%
8/29 • Number of events 14 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
General disorders
Rigors / chills
|
6.9%
2/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Cardiac disorders
Sinus Tachycardia
|
27.6%
8/29 • Number of events 10 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Metabolism and nutrition disorders
Taste Alteration (dysgeusia)
|
10.3%
3/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Vascular disorders
Thrombosis / embolism (vascular access-related)
|
10.3%
3/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Nervous system disorders
Tremor
|
10.3%
3/29 • Number of events 3 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Renal and urinary disorders
polyuria (Urinary frequency / urgency)
|
6.9%
2/29 • Number of events 2 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Eye disorders
Vision - blurred vision
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Eye disorders
photophobia
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Gastrointestinal disorders
Vomiting
|
34.5%
10/29 • Number of events 26 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
|
General disorders
Weight gain
|
3.4%
1/29 • Number of events 1 • adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place