Trial Outcomes & Findings for Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus (NCT NCT00076752)
NCT ID: NCT00076752
Last Updated: 2021-01-05
Results Overview
Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of ≤3; prednisone ≤10mg/day at 6 months and ≤5mg/day at 12 months or later.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
60 months
Results posted on
2021-01-05
Participant Flow
Participant milestones
| Measure |
Autologous HSCT in SLE
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
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|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Autologous HSCT in SLE
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
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|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal per PI, PI put study on hold
|
1
|
Baseline Characteristics
Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Autologous HSCT in SLE
n=9 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion.
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|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.85 years
STANDARD_DEVIATION 7.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: Ninth participant was taken off study before proceeding with transplant per principal investigator due to decision to put study on hold.
Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of ≤3; prednisone ≤10mg/day at 6 months and ≤5mg/day at 12 months or later.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
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|---|---|
|
Relapse-free Complete Clinical Response
|
54 Months
Interval 36.0 to 60.0
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SECONDARY outcome
Timeframe: 18 monthsHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=9 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
|
|---|---|
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Number of Participants With Adverse Events
|
8 participants
|
SECONDARY outcome
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
Anti-Nuclear antibody is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-0.9 EU.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
|
|---|---|
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Anti-Nuclear Antibody
6 months
|
2.7 EU
Standard Deviation 3.01
|
|
Anti-Nuclear Antibody
Day -7
|
5.4 EU
Standard Deviation 4.65
|
|
Anti-Nuclear Antibody
Day 0
|
4.7 EU
Standard Deviation 4.73
|
|
Anti-Nuclear Antibody
1 month
|
3.7 EU
Standard Deviation 3.89
|
|
Anti-Nuclear Antibody
3 months
|
3.2 EU
Standard Deviation 3.91
|
|
Anti-Nuclear Antibody
1 year
|
2.6 EU
Standard Deviation 2.77
|
|
Anti-Nuclear Antibody
18 months
|
2.8 EU
Standard Deviation 2.7
|
|
Anti-Nuclear Antibody
2 years
|
2.5 EU
Standard Deviation 2.59
|
|
Anti-Nuclear Antibody
3 years 9
|
2.5 EU
Standard Deviation 2.96
|
SECONDARY outcome
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
Extractable nuclear antigen is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-19.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
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|---|---|
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Extractable Nuclear Antigen (ENA)
Day -7
|
66.9 EU
Standard Deviation 74.48
|
|
Extractable Nuclear Antigen (ENA)
Day 0
|
64.8 EU
Standard Deviation 70.61
|
|
Extractable Nuclear Antigen (ENA)
1 month
|
61.5 EU
Standard Deviation 73.72
|
|
Extractable Nuclear Antigen (ENA)
3 months
|
58.5 EU
Standard Deviation 67.03
|
|
Extractable Nuclear Antigen (ENA)
6 months
|
51.3 EU
Standard Deviation 57.22
|
|
Extractable Nuclear Antigen (ENA)
1 year
|
57.2 EU
Standard Deviation 58.07
|
|
Extractable Nuclear Antigen (ENA)
18 months
|
60.6 EU
Standard Deviation 60.76
|
|
Extractable Nuclear Antigen (ENA)
2 years
|
50.6 EU
Standard Deviation 49.04
|
|
Extractable Nuclear Antigen (ENA)
3 years
|
26.3 EU
Standard Deviation 41.12
|
SECONDARY outcome
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
Anti-Double stranded deoxyribonucleic acid antibody is a well accepted biological clinical laboratory marker especially specific for systemic lupus. Range of normal values is 0-24 IU.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
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|---|---|
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Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody
Day -7
|
17.3 IU
Standard Deviation 24.92
|
|
Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody
Day 0
|
8.8 IU
Standard Deviation 16.8
|
|
Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody
1 month
|
0 IU
Standard Deviation 0
|
|
Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody
3 months
|
0 IU
Standard Deviation 0
|
|
Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody
6 months
|
0 IU
Standard Deviation 0
|
|
Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody
1 year
|
0 IU
Standard Deviation 0
|
|
Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody
18 months
|
0 IU
Standard Deviation 0
|
|
Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody
2 years
|
0 IU
Standard Deviation 0
|
|
Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody
3 years
|
0 IU
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months and 2 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
Anti-Smith-Ribonuclear protein antibody is a well accepted biological clinical laboratory marker of systemic lupus.Range of normal values is 0-19 EU.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=5 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
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|---|---|
|
Anti-Smith-Ribonuclear Protein Antibody
Day -7
|
49 EU
Standard Deviation 49.51
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|
Anti-Smith-Ribonuclear Protein Antibody
Day 0
|
51.6 EU
Standard Deviation 53.72
|
|
Anti-Smith-Ribonuclear Protein Antibody
1 month
|
31.5 EU
Standard Deviation 40.31
|
|
Anti-Smith-Ribonuclear Protein Antibody
3 months
|
29.8 EU
Standard Deviation 41.48
|
|
Anti-Smith-Ribonuclear Protein Antibody
6 months
|
28.5 EU
Standard Deviation 40.07
|
|
Anti-Smith-Ribonuclear Protein Antibody
1 year
|
20 EU
Standard Deviation 34.64
|
|
Anti-Smith-Ribonuclear Protein Antibody
18 months
|
16.67 EU
Standard Deviation 28.87
|
|
Anti-Smith-Ribonuclear Protein Antibody
2 years
|
25.67 EU
Standard Deviation 44.46
|
SECONDARY outcome
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
The white blood cell test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 3.4-9.6 K/uL.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
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|---|---|
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White Blood Cells
Day -7
|
6.89 K/uL
Standard Deviation 3.07
|
|
White Blood Cells
Day 0
|
0.47 K/uL
Standard Deviation 0.31
|
|
White Blood Cells
1 month
|
10.32 K/uL
Standard Deviation 6.6
|
|
White Blood Cells
3 months
|
3.84 K/uL
Standard Deviation 1.4
|
|
White Blood Cells
6 months
|
4.21 K/uL
Standard Deviation 1.38
|
|
White Blood Cells
1 year
|
5.81 K/uL
Standard Deviation 1.01
|
|
White Blood Cells
18 months
|
5.24 K/uL
Standard Deviation 0.82
|
|
White Blood Cells
2 years
|
7.17 K/uL
Standard Deviation 3.93
|
|
White Blood Cells
3 years
|
6.34 K/uL
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
The absolute neutrophil count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 1.29-7.5 K/uL.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
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|---|---|
|
Absolute Neutrophil Count
Day -7
|
5.66 K/uL
Standard Deviation 2.88
|
|
Absolute Neutrophil Count
Day 0
|
0.45 K/uL
Standard Deviation 0.3
|
|
Absolute Neutrophil Count
1 month
|
9.11 K/uL
Standard Deviation 6.67
|
|
Absolute Neutrophil Count
3 months
|
2.72 K/uL
Standard Deviation 0.93
|
|
Absolute Neutrophil Count
6 months
|
2.78 K/uL
Standard Deviation 1.38
|
|
Absolute Neutrophil Count
1 year
|
3.44 K/uL
Standard Deviation 0.97
|
|
Absolute Neutrophil Count
18 months
|
2.72 K/uL
Standard Deviation 1.04
|
|
Absolute Neutrophil Count
2 years
|
4.04 K/uL
Standard Deviation 1.7
|
|
Absolute Neutrophil Count
3 years
|
3.77 K/uL
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
The absolute lymphocyte count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 0.45-4.9 K/uL.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
|
|---|---|
|
Absolute Lymphocyte Count
Day -7
|
0.54 K/uL
Standard Deviation 0.4
|
|
Absolute Lymphocyte Count
Day 0
|
0.0065 K/uL
Standard Deviation 0.0064
|
|
Absolute Lymphocyte Count
1 month
|
0.42 K/uL
Standard Deviation 0.18
|
|
Absolute Lymphocyte Count
3 months
|
0.53 K/uL
Standard Deviation 0.46
|
|
Absolute Lymphocyte Count
6 months
|
0.82 K/uL
Standard Deviation 0.31
|
|
Absolute Lymphocyte Count
1 year
|
1.75 K/uL
Standard Deviation 0.64
|
|
Absolute Lymphocyte Count
18 months
|
1.8 K/uL
Standard Deviation 0.61
|
|
Absolute Lymphocyte Count
2 years
|
1.8 K/uL
Standard Deviation 0.84
|
|
Absolute Lymphocyte Count
3 years
|
1.75 K/uL
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
The platelet count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 162-380 K/uL.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
|
|---|---|
|
Platelet Count
Day -7
|
251 K/uL
Standard Deviation 62.9
|
|
Platelet Count
Day 0
|
113 K/uL
Standard Deviation 49
|
|
Platelet Count
1 month
|
166 K/uL
Standard Deviation 61.6
|
|
Platelet Count
3 months
|
187 K/uL
Standard Deviation 95.4
|
|
Platelet Count
6 months
|
170 K/uL
Standard Deviation 64
|
|
Platelet Count
1 year
|
226 K/uL
Standard Deviation 47.9
|
|
Platelet Count
18 months
|
210 K/uL
Standard Deviation 43.5
|
|
Platelet Count
2 years
|
308 K/uL
Standard Deviation 251.5
|
|
Platelet Count
3 years
|
272 K/uL
Standard Deviation 125.4
|
SECONDARY outcome
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
The CD3+Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 650-2108 uL.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
|
|---|---|
|
Cluster of Differentiation 3 (CD3) + Cells
Day 0
|
2.99 cells/mL^3
Standard Deviation 3.25
|
|
Cluster of Differentiation 3 (CD3) + Cells
1 month
|
239.47 cells/mL^3
Standard Deviation 210.74
|
|
Cluster of Differentiation 3 (CD3) + Cells
3 months
|
435.97 cells/mL^3
Standard Deviation 335.69
|
|
Cluster of Differentiation 3 (CD3) + Cells
6 months
|
699.47 cells/mL^3
Standard Deviation 256.67
|
|
Cluster of Differentiation 3 (CD3) + Cells
1 year
|
1493.29 cells/mL^3
Standard Deviation 605.26
|
|
Cluster of Differentiation 3 (CD3) + Cells
2 years
|
1678.76 cells/mL^3
Standard Deviation 888.41
|
SECONDARY outcome
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
The CD4 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 358-1259 uL.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
|
|---|---|
|
Cluster of Differentiation 4 (CD4) + Cells
Day 0
|
2.58 cells/mL^3
Standard Deviation 2.98
|
|
Cluster of Differentiation 4 (CD4) + Cells
1 month
|
103.37 cells/mL^3
Standard Deviation 117.43
|
|
Cluster of Differentiation 4 (CD4) + Cells
3 months
|
112.8 cells/mL^3
Standard Deviation 101.94
|
|
Cluster of Differentiation 4 (CD4) + Cells
6 months
|
316.25 cells/mL^3
Standard Deviation 193.01
|
|
Cluster of Differentiation 4 (CD4) + Cells
1 year
|
702.87 cells/mL^3
Standard Deviation 362.75
|
|
Cluster of Differentiation 4 (CD4) + Cells
2 years
|
958.03 cells/mL^3
Standard Deviation 735.04
|
SECONDARY outcome
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
The CD8 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 194-836 u/L.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
|
|---|---|
|
Cluster of Differentiation 8 (CD8) + Cells
Day 0
|
0.34 cells/mL^3
Standard Deviation 0.34
|
|
Cluster of Differentiation 8 (CD8) + Cells
1 month
|
138.68 cells/mL^3
Standard Deviation 112.61
|
|
Cluster of Differentiation 8 (CD8) + Cells
3 months
|
318.47 cells/mL^3
Standard Deviation 259.28
|
|
Cluster of Differentiation 8 (CD8) + Cells
6 months
|
334.91 cells/mL^3
Standard Deviation 139.55
|
|
Cluster of Differentiation 8 (CD8) + Cells
1 year
|
736.67 cells/mL^3
Standard Deviation 532.19
|
|
Cluster of Differentiation 8 (CD8) + Cells
2 years
|
674.69 cells/mL^3
Standard Deviation 378.6
|
SECONDARY outcome
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
The CD19 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 47-409 u/L.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
|
|---|---|
|
Cluster of Differentiation 19 (CD19) + Cells
Day 0
|
0.01 cells/mL^3
Standard Deviation 0.02
|
|
Cluster of Differentiation 19 (CD19) + Cells
1 month
|
0.23 cells/mL^3
Standard Deviation 0.32
|
|
Cluster of Differentiation 19 (CD19) + Cells
3 months
|
6.7 cells/mL^3
Standard Deviation 17.22
|
|
Cluster of Differentiation 19 (CD19) + Cells
6 months
|
45.32 cells/mL^3
Standard Deviation 58.21
|
|
Cluster of Differentiation 19 (CD19) + Cells
1 year
|
142.69 cells/mL^3
Standard Deviation 116.24
|
|
Cluster of Differentiation 19 (CD19) + Cells
3 years
|
246.83 cells/mL^3
Standard Deviation 316.53
|
SECONDARY outcome
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
The natural killer cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 87-505 uL.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
|
|---|---|
|
Natural Killer Cells
Day 0
|
0.03 cells/mL^3
Standard Deviation 0.035
|
|
Natural Killer Cells
1 month
|
117.06 cells/mL^3
Standard Deviation 81.76
|
|
Natural Killer Cells
3 months
|
116.57 cells/mL^3
Standard Deviation 93.57
|
|
Natural Killer Cells
6 months
|
123.18 cells/mL^3
Standard Deviation 63.32
|
|
Natural Killer Cells
1 year
|
158.9 cells/mL^3
Standard Deviation 136.42
|
|
Natural Killer Cells
3 years
|
115.18 cells/mL^3
Standard Deviation 68.3
|
SECONDARY outcome
Timeframe: Day -7, day 0, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years and 3 years.Population: One participant was enrolled but the study was closed before the patient could be treated.
The SLEDAI activity index test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a SLEDAI score of ≤3; partial response is at least 50% improvement in general disease activity as measured by SLEDAI. Remission is a SLEDAI score \<3 and prednisone \<10mg/day. 6+ indicates active disease requiring therapy. A score of 0 indicates a better outcome and a score greater then 6+ indicates a worse outcome.
Outcome measures
| Measure |
Autologous HSCT in SLE
n=8 Participants
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
|
|---|---|
|
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Day -7
|
4.25 scores on a scale.
Standard Deviation 3.28
|
|
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Day 0
|
4.13 scores on a scale.
Standard Deviation 4.49
|
|
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
1 month
|
3.63 scores on a scale.
Standard Deviation 2.83
|
|
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
3 months
|
1.6 scores on a scale.
Standard Deviation 3.58
|
|
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
6 months
|
0 scores on a scale.
Standard Deviation 0
|
|
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
1 year
|
0 scores on a scale.
Standard Deviation 0
|
|
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
18 months
|
0 scores on a scale.
Standard Deviation 0
|
|
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
2 years
|
0 scores on a scale.
Standard Deviation 0
|
|
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
3 years
|
0 scores on a scale.
Standard Deviation 0
|
Adverse Events
Autologous HSCT in SLE
Serious events: 8 serious events
Other events: 8 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Autologous HSCT in SLE
n=9 participants at risk
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion.
|
|---|---|
|
Immune system disorders
allergic reaction/hypersensitivity (including drug fever)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Cardiac disorders
conduction abnormality/atrioventricular heart block: asystole
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Cardiac disorders
hypertension
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
gastrointestinal-Other (Specify)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Infections and infestations
infection
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Infections and infestations
infection - Other (Specify, CMV antigenemia without neutropenia)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
ALT/SGPT (serum glutamic pyruvic transaminase)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
AST/SGOT (serum glutamic oxaloacetic transaminase)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
potassium, serum-high (hyperkalemia)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
sodium, serum-low (hyponatremia)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Nervous system disorders
encephalopathy
|
11.1%
1/9 • Number of events 2 • 18 months
|
|
Nervous system disorders
hydrocephalus
|
11.1%
1/9 • Number of events 2 • 18 months
|
|
Nervous system disorders
neuropathy: motor
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Nervous system disorders
neuropathy: sensory
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
22.2%
2/9 • Number of events 3 • 18 months
|
|
General disorders
Death Not Associated with CTCAE term: Death NOS
|
22.2%
2/9 • Number of events 2 • 18 months
|
Other adverse events
| Measure |
Autologous HSCT in SLE
n=9 participants at risk
Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion.
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify, __)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify, __)
|
11.1%
1/9 • Number of events 2 • 18 months
|
|
Blood and lymphatic system disorders
Bone marrow cellularity
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
88.9%
8/9 • Number of events 55 • 18 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
88.9%
8/9 • Number of events 82 • 18 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
88.9%
8/9 • Number of events 79 • 18 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
88.9%
8/9 • Number of events 81 • 18 months
|
|
Blood and lymphatic system disorders
Platelets
|
88.9%
8/9 • Number of events 130 • 18 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia:: Atrial fibrillation
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia:: Supraventricular arrhythmia NOS
|
11.1%
1/9 • Number of events 3 • 18 months
|
|
Cardiac disorders
Ventricular arrhythmia:: PVCs
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Cardiac disorders
Ventricular arrhythmia:: Ventricular tachycardia
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Cardiac disorders
Cardiac General - Other (Specify, __)
|
11.1%
1/9 • Number of events 7 • 18 months
|
|
Cardiac disorders
Cardiac troponin I (cTnI)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Cardiac disorders
Hypertension
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Cardiac disorders
Hypotension
|
44.4%
4/9 • Number of events 4 • 18 months
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
44.4%
4/9 • Number of events 8 • 18 months
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
General disorders
Constitutional Symptoms - Other (Specify,decreased appetite )
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
33.3%
3/9 • Number of events 8 • 18 months
|
|
General disorders
Rigors/chills
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, scalp dermatitis)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
33.3%
3/9 • Number of events 3 • 18 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
22.2%
2/9 • Number of events 3 • 18 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
11.1%
1/9 • Number of events 3 • 18 months
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Endocrine disorders
Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Endocrine disorders
Masculinization of female
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Anorexia
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
4/9 • Number of events 5 • 18 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam):: Oral cavity
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
55.6%
5/9 • Number of events 9 • 18 months
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
44.4%
4/9 • Number of events 8 • 18 months
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding - Other (Specify,bruising-skin)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Blood and lymphatic system disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
22.2%
2/9 • Number of events 3 • 18 months
|
|
Hepatobiliary disorders
Cholecystitis
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Infections and infestations
Febrile neutropenia
|
33.3%
3/9 • Number of events 4 • 18 months
|
|
Infections and infestations
Infection
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Infections and infestations
Infection - Other (Specify, __)
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:: Abdomen NOS
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:: Blood
|
44.4%
4/9 • Number of events 8 • 18 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:: Bone (osteomyelitis)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:: Catheter-related
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:: Colon
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:: Conjunctiva
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:: Eye NOS
|
11.1%
1/9 • Number of events 2 • 18 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:: Lung (pneumonia)
|
22.2%
2/9 • Number of events 3 • 18 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:: Pharynx
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:: Sinus
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:: Small bowel NOS
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:: Upper airway NOS
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:: Urinary tract NOS
|
33.3%
3/9 • Number of events 4 • 18 months
|
|
Infections and infestations
Infection with unknown ANC:: Middle ear (otitis media)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Infections and infestations
Infection with unknown ANC:: Urinary tract NOS
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Blood and lymphatic system disorders
Edema: limb
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
55.6%
5/9 • Number of events 36 • 18 months
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
55.6%
5/9 • Number of events 41 • 18 months
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
55.6%
5/9 • Number of events 31 • 18 months
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
44.4%
4/9 • Number of events 25 • 18 months
|
|
Metabolism and nutrition disorders
Amylase
|
33.3%
3/9 • Number of events 6 • 18 months
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
33.3%
3/9 • Number of events 8 • 18 months
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
11.1%
1/9 • Number of events 6 • 18 months
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
11.1%
1/9 • Number of events 2 • 18 months
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
88.9%
8/9 • Number of events 67 • 18 months
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
Creatinine
|
33.3%
3/9 • Number of events 9 • 18 months
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
55.6%
5/9 • Number of events 24 • 18 months
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
11.1%
1/9 • Number of events 5 • 18 months
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
33.3%
3/9 • Number of events 16 • 18 months
|
|
Metabolism and nutrition disorders
Lipase
|
22.2%
2/9 • Number of events 5 • 18 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
33.3%
3/9 • Number of events 13 • 18 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
44.4%
4/9 • Number of events 10 • 18 months
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
77.8%
7/9 • Number of events 86 • 18 months
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
55.6%
5/9 • Number of events 16 • 18 months
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
55.6%
5/9 • Number of events 14 • 18 months
|
|
Metabolism and nutrition disorders
Proteinuria
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
44.4%
4/9 • Number of events 8 • 18 months
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
22.2%
2/9 • Number of events 6 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
11.1%
1/9 • Number of events 2 • 18 months
|
|
Nervous system disorders
Memory impairment
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Nervous system disorders
Mood alteration:: Agitation
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Nervous system disorders
Mood alteration:: Anxiety
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Nervous system disorders
Mood alteration:: Depression
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Nervous system disorders
Neuropathy: sensory
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
Eye disorders
Retinopathy
|
11.1%
1/9 • Number of events 2 • 18 months
|
|
Eye disorders
Vision-blurred vision
|
44.4%
4/9 • Number of events 4 • 18 months
|
|
Eye disorders
Vision-photophobia
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
General disorders
Pain - Other (Specify, __)
|
11.1%
1/9 • Number of events 2 • 18 months
|
|
Gastrointestinal disorders
Pain:: Abdomen NOS
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain:: Back
|
55.6%
5/9 • Number of events 7 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain:: Bone
|
55.6%
5/9 • Number of events 7 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain:: Chest wall
|
33.3%
3/9 • Number of events 4 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain:: Chest/thorax NOS
|
44.4%
4/9 • Number of events 4 • 18 months
|
|
Ear and labyrinth disorders
Pain:: External ear
|
11.1%
1/9 • Number of events 1 • 18 months
|
|
Eye disorders
Pain:: Eye
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
Nervous system disorders
Pain:: Head/headache
|
55.6%
5/9 • Number of events 5 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain:: Muscle
|
11.1%
1/9 • Number of events 2 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain:: Neck
|
33.3%
3/9 • Number of events 6 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx
|
22.2%
2/9 • Number of events 2 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Carbon monoxide diffusion capacity (DL(co))
|
11.1%
1/9 • Number of events 2 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.4%
4/9 • Number of events 5 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
55.6%
5/9 • Number of events 9 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
44.4%
4/9 • Number of events 4 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
44.4%
4/9 • Number of events 4 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
22.2%
2/9 • Number of events 3 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
11.1%
1/9 • Number of events 2 • 18 months
|
|
Renal and urinary disorders
Cystitis
|
11.1%
1/9 • Number of events 1 • 18 months
|
Additional Information
Dr. Steven Pavletic
National Cancer Institute, National Institutes of Health
Phone: 301-402-4899
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place