Trial Outcomes & Findings for T-Reg Cell Kinetics, Stem Cell Transplant, REGALE (NCT NCT00578539)
NCT ID: NCT00578539
Last Updated: 2016-04-22
Results Overview
To define the biologic recovery and behavior of T regulatory cells for patients undergoing stem cell transplantation as specified in this protocol
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
1 year
Results posted on
2016-04-22
Participant Flow
Participant milestones
| Measure |
Stem Cell Transplant
All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
T-Reg Cell Kinetics, Stem Cell Transplant, REGALE
Baseline characteristics by cohort
| Measure |
Stem Cell Transplant
n=24 Participants
All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
|
|---|---|
|
Age, Continuous
|
10.0 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Only 13 of the 24 patients enrolled were included in this analysis as only 13 patients have Treg values at 1 year.
To define the biologic recovery and behavior of T regulatory cells for patients undergoing stem cell transplantation as specified in this protocol
Outcome measures
| Measure |
Stem Cell Transplant
n=13 Participants
All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
|
|---|---|
|
Median Percentage of Treg Cells at 1 Year Post Transplant
|
6.9 percentage of total CD4+ cells
Interval 4.6 to 13.2
|
Adverse Events
Stem Cell Transplant
Serious events: 17 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stem Cell Transplant
n=24 participants at risk
All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
|
|---|---|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
4.2%
1/24 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary arrest, cause unknown (non-fatal)
|
4.2%
1/24 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Death
|
4.2%
1/24 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS
|
4.2%
1/24 • Number of events 1
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Bladder (urinary)
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Blood
|
12.5%
3/24 • Number of events 4
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Bronchus
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Lung (pneumonia)
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Urinary tract NOS
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Infection - Other: Multiple viral infections
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Infection - Other: Probable fungal disease
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Abdomen NOS
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
|
12.5%
3/24 • Number of events 6
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
|
12.5%
3/24 • Number of events 4
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper aerodigestive NOS
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
|
8.3%
2/24 • Number of events 3
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
4.2%
1/24 • Number of events 1
|
|
Metabolism and nutrition disorders
AST, SGOT
|
8.3%
2/24 • Number of events 2
|
|
Nervous system disorders
Neurology - Other: Aseptic meningitis
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Neurology - Other: Cranial nerve VI palsy
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Neurology - Other: Peripheral neuropathy
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: Acute respiratory failure
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: Respiratory distress: dyspnea + hypoxia
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: Respiratory failure
|
4.2%
1/24 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
4.2%
1/24 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
12.5%
3/24 • Number of events 3
|
|
Vascular disorders
Vascular - Other: Vaso Oclusive Disease
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Pain - Abdomen NOS
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
Stem Cell Transplant
n=24 participants at risk
All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
12.5%
3/24 • Number of events 3
|
|
Infections and infestations
Infection - Other: CMV viremia
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Blood
|
8.3%
2/24 • Number of events 2
|
|
Metabolism and nutrition disorders
AST, SGOT
|
8.3%
2/24 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
8.3%
2/24 • Number of events 2
|
|
Cardiac disorders
Hypotension
|
8.3%
2/24 • Number of events 2
|
|
Vascular disorders
PTT
|
8.3%
2/24 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
2/24 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
16.7%
4/24 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
12.5%
3/24 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place