Trial Outcomes & Findings for Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (NCT NCT01894477)
NCT ID: NCT01894477
Last Updated: 2021-06-03
Results Overview
Progression is defined as relapse
UNKNOWN
PHASE2
102 participants
At 6 months post-transplant
2021-06-03
Participant Flow
Participant milestones
| Measure |
Arm A (Treosulfan, Fludarabine Phosphate)
CONDITIONING REGIMEN:
Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: Patients in both arms undergo allogeneic PBSC transplant or bone marrow transplant on day 0.
GVHD PROPHYLAXIS: Patients with related donor receive tacrolimus PO every 8 or 12 hours on days -3 to 56 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 12 hours to day 28. Patients with an unrelated donor receive tacrolimus PO every 8 or 12 hours on days -3 to 100 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 8 hours to day 40 with taper to day 96.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC
|
Arm B (Treosulfan, Fludarabine Phosphate, TBI)
CONDITIONING REGIMEN: Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
TRANSPLANT: Patients in both arms undergo allogeneic PBSC transplant or bone marrow transplant on day 0.
GVHD PROPHYLAXIS: Patients with a related donor receive tacrolimus PO every 8 or 12 hours on days -3 to 56 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 12 hours to day 28. Patients with an unrelated donor receive tacrolimus PO every 8 or 12 hours on days -3 to 100 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 8 hours to day 40 with taper to day 96.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Fludarabine Phosphate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Total-Body Irradation
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
67
|
|
Overall Study
COMPLETED
|
35
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Arm A (Treosulfan, Fludarabine Phosphate)
CONDITIONING REGIMEN:
Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: Patients in both arms undergo allogeneic PBSC transplant or bone marrow transplant on day 0.
GVHD PROPHYLAXIS: Patients with related donor receive tacrolimus PO every 8 or 12 hours on days -3 to 56 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 12 hours to day 28. Patients with an unrelated donor receive tacrolimus PO every 8 or 12 hours on days -3 to 100 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 8 hours to day 40 with taper to day 96.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC
|
Arm B (Treosulfan, Fludarabine Phosphate, TBI)
CONDITIONING REGIMEN: Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
TRANSPLANT: Patients in both arms undergo allogeneic PBSC transplant or bone marrow transplant on day 0.
GVHD PROPHYLAXIS: Patients with a related donor receive tacrolimus PO every 8 or 12 hours on days -3 to 56 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 12 hours to day 28. Patients with an unrelated donor receive tacrolimus PO every 8 or 12 hours on days -3 to 100 with taper to day 180. Beginning 4-6 hours after PBSC infusion, and mycophenolate mofetil PO every 8 hours to day 40 with taper to day 96.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Fludarabine Phosphate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Total-Body Irradation
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
protocol changed due SC changed to cord
|
0
|
1
|
Baseline Characteristics
Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm A (Treosulfan, Fludarabine Phosphate)
n=35 Participants
Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
|
Arm B (Treosulfan, Fludarabine Phosphate, TBI)
n=65 Participants
Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
63 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Region of Enrollment
Indonesia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Samoa
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 months post-transplantProgression is defined as relapse
Outcome measures
| Measure |
Arm A (Treosulfan, Fludarabine Phosphate)
n=35 Participants
Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
|
Arm B (Treosulfan, Fludarabine Phosphate, TBI)
n=65 Participants
Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
|
|---|---|---|
|
Number of Participants That Did Not Progress Within 6 Months
|
20 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Up to 84 daysOutcome measures
| Measure |
Arm A (Treosulfan, Fludarabine Phosphate)
n=35 Participants
Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
|
Arm B (Treosulfan, Fludarabine Phosphate, TBI)
n=65 Participants
Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
|
|---|---|---|
|
Number of Participants With Acute GVHD, Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
|
29 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and at day 0 within 6 hours of conditioning prior to transplantDifferences between arms in the changes in gene expression will be compared. 80% power to detect mean differences of approximately 1.4 standard deviation units, at the 2-sided 0.05 level of significance (with Bonferroni correction for 50 genes).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and at day 0 within 6 hours of conditioning prior to transplantAmong genes identified whose expression is modified by conditioning, degree of change in expression will be evaluated to determine if it is correlated with relapse risk and offers improved prediction of relapse risk over that obtained with standard clinical parameters (cytogenetics, blast count, International Prognostic Scoring System score, minimal residual disease. To account for censoring and the competing risk of non-relapse mortality (NRM), the analysis will be a time-to-event analysis of relapse using Cox regression, with change in expression as a continuous covariate (on a log scale). 8
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Treosulfan, Fludarabine Phosphate)
Arm B (Treosulfan, Fludarabine Phosphate, TBI)
Serious adverse events
| Measure |
Arm A (Treosulfan, Fludarabine Phosphate)
n=35 participants at risk
Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
|
Arm B (Treosulfan, Fludarabine Phosphate, TBI)
n=67 participants at risk
Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
|
|---|---|---|
|
Gastrointestinal disorders
GI bleed
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Cardiac disorders
pericardial effusion
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Gastrointestinal disorders
CMV Gastritis
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Eye disorders
loss of vision
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Immune system disorders
Engraftment syndrome
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Psychiatric disorders
mental status changes
|
5.7%
2/35 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.6%
3/35 • Number of events 3 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
4.5%
3/67 • Number of events 3 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Infections and infestations
Infection
|
5.7%
2/35 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
6.0%
4/67 • Number of events 4 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Vascular disorders
Hypotension
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar hemorrhage
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Blood and lymphatic system disorders
Post Transplant Lymphoproliferative Disorder
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Hepatobiliary disorders
Liver failure
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Renal and urinary disorders
Renal failure
|
5.7%
2/35 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
General disorders
Total body edema
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Musculoskeletal and connective tissue disorders
Steroid myopathy
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
Other adverse events
| Measure |
Arm A (Treosulfan, Fludarabine Phosphate)
n=35 participants at risk
Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
|
Arm B (Treosulfan, Fludarabine Phosphate, TBI)
n=67 participants at risk
Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation/flutter
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
4.5%
3/67 • Number of events 3 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Cardiac disorders
Decreased LVEF
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
3.0%
2/67 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Cardiac disorders
bradycardia
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Cardiac disorders
pericardial effusion
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Cardiac disorders
Elevated BNP
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
General disorders
Deconditioned
|
8.6%
3/35 • Number of events 3 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
3.0%
2/67 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
General disorders
Edema
|
5.7%
2/35 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
General disorders
Fluid overload
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
General disorders
Weakness
|
11.4%
4/35 • Number of events 4 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
6.0%
4/67 • Number of events 4 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Gastrointestinal disorders
Nausea
|
17.1%
6/35 • Number of events 6 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
20.9%
14/67 • Number of events 14 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
7/35 • Number of events 7 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
13.4%
9/67 • Number of events 9 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
2/35 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
3.0%
2/67 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Gastrointestinal disorders
Anorexia
|
11.4%
4/35 • Number of events 4 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
10.4%
7/67 • Number of events 7 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Gastrointestinal disorders
abdominal pain
|
5.7%
2/35 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
3.0%
2/67 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Gastrointestinal disorders
mucositis
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
7.5%
5/67 • Number of events 5 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Gastrointestinal disorders
Typhilitis
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Gastrointestinal disorders
Ascites
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Gastrointestinal disorders
Diverticulitis
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Hepatobiliary disorders
Elevated total bilirubin
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
3.0%
2/67 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Hepatobiliary disorders
Elevated Alanine transaminase
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Hepatobiliary disorders
sinusoidal obstruction syndrome
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Immune system disorders
Engraftment syndrome
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Infections and infestations
Infections
|
57.1%
20/35 • Number of events 35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
49.3%
33/67 • Number of events 54 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Musculoskeletal and connective tissue disorders
Steroid myopathy
|
5.7%
2/35 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
4.5%
3/67 • Number of events 3 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Musculoskeletal and connective tissue disorders
pain
|
20.0%
7/35 • Number of events 7 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
10.4%
7/67 • Number of events 7 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia/Arthralgia
|
8.6%
3/35 • Number of events 3 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
3.0%
2/67 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Musculoskeletal and connective tissue disorders
Compression fracture
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Musculoskeletal and connective tissue disorders
Septic arthritis
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.7%
2/35 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
4.5%
3/67 • Number of events 3 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.1%
6/35 • Number of events 6 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
7.5%
5/67 • Number of events 5 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Metabolism and nutrition disorders
Hypermagnesia
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminenia
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Nervous system disorders
Peripheral neuropathy
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
13.4%
9/67 • Number of events 9 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Nervous system disorders
Headache
|
5.7%
2/35 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
3.0%
2/67 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Nervous system disorders
Seizure
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Nervous system disorders
Syncope
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Blood and lymphatic system disorders
Posttransplant lymphoproliferative disease (PTLD-DLBC)
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Psychiatric disorders
mental status changes
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
4.5%
3/67 • Number of events 3 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Renal and urinary disorders
Elevated creatinine
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Renal and urinary disorders
Bladder spasms
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
4.5%
3/67 • Number of events 3 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
3.0%
2/67 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.7%
2/35 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
9.0%
6/67 • Number of events 6 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.6%
3/35 • Number of events 3 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
3.0%
2/67 • Number of events 2 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/35 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
1.5%
1/67 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Skin and subcutaneous tissue disorders
Peeling blisters
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
0.00%
0/67 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
4.5%
3/67 • Number of events 3 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
|
Vascular disorders
Hypotension
|
2.9%
1/35 • Number of events 1 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
10.4%
7/67 • Number of events 7 • Regimen-related toxicity and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100.
Regimen-related toxicity, greater or equal to grade 3, excluding cytopenias, and infection will be evaluated up to the time the patient is discharged from medical care at the transplant institution, or day 100. Toxicities will be documented per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All patients undergoing HCT are expected to have Grade 3 and 4 pancytopenia as an intended therapeutic effect, and thus this will not be reported as an adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place