Trial Outcomes & Findings for Stem Cell Transplant for Immunologic or Histiocytic Disorders (NCT NCT00176865)
NCT ID: NCT00176865
Last Updated: 2017-12-28
Results Overview
\>10% Donor Cells at Day 100
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Day 100
Results posted on
2017-12-28
Participant Flow
Participant milestones
| Measure |
Arm 1 - Matched Sibling Donor
human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 2 - Matched Unrelated Donor
HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 3 - Mismatched Double Cord Donors
two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
10
|
6
|
|
Overall Study
COMPLETED
|
3
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stem Cell Transplant for Immunologic or Histiocytic Disorders
Baseline characteristics by cohort
| Measure |
Arm 1 - Matched Sibling Donor
n=3 Participants
human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 2 - Matched Unrelated Donor
n=10 Participants
HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 3 - Mismatched Double Cord Donors
n=6 Participants
two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
6 participants
n=5 Participants
|
19 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 100Population: Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation. Arm 3: 2 of 6 patients not evaluable due to early death.
\>10% Donor Cells at Day 100
Outcome measures
| Measure |
Arm 1 - Matched Sibling Donor
n=3 Participants
human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 2 - Matched Unrelated Donor
n=8 Participants
HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 3 - Mismatched Double Cord Donors
n=4 Participants
two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
|---|---|---|---|
|
Number of Subjects With Mixed Chimerism
|
3 participants
|
8 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Day 100Population: Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation. Arm 3: 2 of 6 patients not evaluable due to early death.
The percent of recipient bone marrow and blood cells that are of donor origin.
Outcome measures
| Measure |
Arm 1 - Matched Sibling Donor
n=3 Participants
human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 2 - Matched Unrelated Donor
n=8 Participants
HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 3 - Mismatched Double Cord Donors
n=4 Participants
two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
|---|---|---|---|
|
Percentage of Donor Chimerism at 100 Days
|
96.5 percentage of donor cells
Standard Deviation 6.0
|
75.5 percentage of donor cells
Standard Deviation 37.3
|
100 percentage of donor cells
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 180Population: Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation. Arm 3: 2 of 6 patients not evaluable due to early death.
The percent of recipient bone marrow and blood cells that are of donor origin.
Outcome measures
| Measure |
Arm 1 - Matched Sibling Donor
n=3 Participants
human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 2 - Matched Unrelated Donor
n=8 Participants
HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 3 - Mismatched Double Cord Donors
n=4 Participants
two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
|---|---|---|---|
|
Percentage of Donor Chimerism at 180 Days
|
88.9 percentage of donor cells
Standard Deviation 19.2
|
73.3 percentage of donor cells
Standard Deviation 41.7
|
90.5 percentage of donor cells
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: Day 365Population: Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation. Arm 3: 2 of 6 patients not evaluable due to early death.
The percent of recipient bone marrow and blood cells that are of donor origin.
Outcome measures
| Measure |
Arm 1 - Matched Sibling Donor
n=3 Participants
human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 2 - Matched Unrelated Donor
n=8 Participants
HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 3 - Mismatched Double Cord Donors
n=4 Participants
two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
|---|---|---|---|
|
Percentage of Donor Chimerism at 365 Days
|
81.9 percentage of donor cells
Standard Deviation 31.4
|
78.6 percentage of donor cells
Standard Deviation 38.2
|
91.7 percentage of donor cells
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: Day 100Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease.
Outcome measures
| Measure |
Arm 1 - Matched Sibling Donor
n=3 Participants
human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 2 - Matched Unrelated Donor
n=10 Participants
HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 3 - Mismatched Double Cord Donors
n=6 Participants
two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
|---|---|---|---|
|
Incidence of Grade 2-4 Acute Graft Versus Host Disease (aGVHD)
|
1 participants
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 100Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease.
Outcome measures
| Measure |
Arm 1 - Matched Sibling Donor
n=3 Participants
human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 2 - Matched Unrelated Donor
n=10 Participants
HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 3 - Mismatched Double Cord Donors
n=6 Participants
two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
|---|---|---|---|
|
Incidence of Grade 3-4 Acute Graft Versus Host Disease (aGVHD)
|
1 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 months and 1 yearChronic graft versus host disease (cGVHD) is a reaction which typically develops 3 to 6 months after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs.
Outcome measures
| Measure |
Arm 1 - Matched Sibling Donor
n=3 Participants
human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 2 - Matched Unrelated Donor
n=10 Participants
HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 3 - Mismatched Double Cord Donors
n=6 Participants
two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
|---|---|---|---|
|
Incidence of Chronic Graft Versus Host Disease (cGVHD)
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 100Outcome measures
| Measure |
Arm 1 - Matched Sibling Donor
n=3 Participants
human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 2 - Matched Unrelated Donor
n=10 Participants
HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 3 - Mismatched Double Cord Donors
n=6 Participants
two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
|---|---|---|---|
|
Number of Subjects Alive at 100 Days
|
3 participants
|
8 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Day 365Outcome measures
| Measure |
Arm 1 - Matched Sibling Donor
n=3 Participants
human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 2 - Matched Unrelated Donor
n=10 Participants
HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 3 - Mismatched Double Cord Donors
n=6 Participants
two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
|---|---|---|---|
|
Number of Subjects Alive at One Year
|
3 participants
|
7 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Pretransplant, 1 year, 2 years and 5 yearsPopulation: PI made decision after IRB approval, but before opening the study to accrual, to not collect QOL data .
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 - Matched Sibling Donor
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 2 - Matched Unrelated Donor
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm 3 - Mismatched Double Cord Donors
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 - Matched Sibling Donor
n=3 participants at risk
human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 2 - Matched Unrelated Donor
n=10 participants at risk
HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 3 - Mismatched Double Cord Donors
n=6 participants at risk
two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
|---|---|---|---|
|
General disorders
Multi-organ failure
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
Other adverse events
| Measure |
Arm 1 - Matched Sibling Donor
n=3 participants at risk
human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 2 - Matched Unrelated Donor
n=10 participants at risk
HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
Arm 3 - Mismatched Double Cord Donors
n=6 participants at risk
two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemolytic anemia
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Cardiac disorders
Hypertension
|
33.3%
1/3
|
40.0%
4/10
|
16.7%
1/6
|
|
Endocrine disorders
Delayed growth
|
33.3%
1/3
|
20.0%
2/10
|
0.00%
0/6
|
|
Infections and infestations
Infection, GI
|
33.3%
1/3
|
30.0%
3/10
|
33.3%
2/6
|
|
Renal and urinary disorders
Cystitis
|
33.3%
1/3
|
20.0%
2/10
|
0.00%
0/6
|
|
Infections and infestations
Infection, blood
|
33.3%
1/3
|
70.0%
7/10
|
16.7%
1/6
|
|
Psychiatric disorders
Delirious
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/6
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/6
|
|
Psychiatric disorders
Hallucinations
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/6
|
|
Psychiatric disorders
Psychosis
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/6
|
|
Eye disorders
Incipient cataracts, bilateral
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Hearing loss
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Infection, respiratory
|
33.3%
1/3
|
80.0%
8/10
|
83.3%
5/6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
33.3%
1/3
|
20.0%
2/10
|
0.00%
0/6
|
|
Infections and infestations
Infection, skin
|
33.3%
1/3
|
0.00%
0/10
|
0.00%
0/6
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/3
|
10.0%
1/10
|
16.7%
1/6
|
|
Gastrointestinal disorders
GI bleed
|
0.00%
0/3
|
20.0%
2/10
|
16.7%
1/6
|
|
Vascular disorders
Capillary leak
|
0.00%
0/3
|
10.0%
1/10
|
16.7%
1/6
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Colonic pneumatosis
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Erythrodermic dermatitis
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Renal and urinary disorders
Hemorrhagic cystitis
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Hemorrhagic gastritis
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Investigations
Hyperbilirubinemia
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3
|
10.0%
1/10
|
16.7%
1/6
|
|
Psychiatric disorders
ICU dementia
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Infections and infestations
Infection, GU
|
0.00%
0/3
|
30.0%
3/10
|
16.7%
1/6
|
|
Hepatobiliary disorders
Liver failure
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/3
|
10.0%
1/10
|
16.7%
1/6
|
|
Infections and infestations
Otitis
|
0.00%
0/3
|
10.0%
1/10
|
16.7%
1/6
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3
|
10.0%
1/10
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Prerenal azotemia
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Cardiac disorders
Prolonged QTC interval
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Nervous system disorders
Seizure
|
0.00%
0/3
|
10.0%
1/10
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Skin breakdown
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Vascular disorders
Subclavian thrombosis
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Hepatobiliary disorders
Veno-occlusive disease
|
0.00%
0/3
|
10.0%
1/10
|
0.00%
0/6
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6
|
|
Hepatobiliary disorders
Cholestasis portal fibrosis and bile duct proliferation
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6
|
|
Ear and labyrinth disorders
Ear drainage
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6
|
|
Investigations
Elevated liver function tests
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6
|
|
Infections and infestations
Infection, NOS
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6
|
|
Nervous system disorders
Intraparenchymal hemorrhage, left frontal lobe
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6
|
|
Nervous system disorders
Learning dysfunction
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress and apnea
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6
|
|
Endocrine disorders
Syndrome of inappropriate antidiuretic hormone secretion
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6
|
Additional Information
Dr. Angela Smith
Masonic Cancer Center, University of Minnesota
Phone: 612-626-2778
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place