NCT01614197 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 16
- units
- Participants
- groups
- description
- This is the starting dose of temsirolimus at 7.5 mg/m\^2 given IV. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8. Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5. Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.
- id
- BG000
- title
- Dose Level 1
- description
- If Dose Level 1 is tolerated, the study will escalate to Dose Level 2 following the dose escalation schedule. Dose Level 2 will be administered via IV at 10 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8. Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5. Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.
- id
- BG001
- title
- Dose Level 2
- description
- If Dose Level 2 is tolerated, the study will escalate to Dose Level 3 following the dose escalation schedule. Dose Level 3 will be administered via IV at 15 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8. Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5. Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.
- id
- BG002
- title
- Dose Level 3
- description
- If Dose Level 3 is tolerated, the study will escalate to Dose Level 4 following the dose escalation schedule. Dose Level 4 will be administered via IV at 25 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus will not be escalated beyond Dose Level 4. Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8. Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5. Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.
- id
- BG003
- title
- Dose Level 4
- description
- Total of all reporting groups
- id
- BG004
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 16
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 6
- title
- Female
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 10
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 8
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 7
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 1
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 10
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 4
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 2
- title
- Canada
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 13
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 1
- title
- Australia
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- # of prior therapies : 1 prior therapy
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 3
- title
- # of prior therapies : 2 prior therapies
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 5
- title
- # of prior therapies : 3 prior therapies
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- # of prior therapies : 4 prior therapies
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 4
- title
- # of prior therapies : 5 prior therapies
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- # of prior therapies : 6 prior therapies
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 3
- title
- # of prior therapies : 7 prior therapies
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 8
- title
- Prior transplant : Yes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 7
- title
- Prior transplant : No
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 4
- title
- Prior CAR-T cell therapy : Yes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 11
- title
- Prior CAR-T cell therapy : No
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Total number of patients that were enrolled onto the study
- title
- Prior Therapy Regimens
- unit Of Measure
- Participants
- population Description
- Number of patients who were enrolled onto the study
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 16
- units
- Participants
- groups
- description
- This is the starting dose of temsirolimus at 7.5 mg/m\^2 given IV. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8. Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5. Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.
- id
- BG000
- title
- Dose Level 1
- description
- If Dose Level 1 is tolerated, the study will escalate to Dose Level 2 following the dose escalation schedule. Dose Level 2 will be administered via IV at 10 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8. Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5. Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.
- id
- BG001
- title
- Dose Level 2
- description
- If Dose Level 2 is tolerated, the study will escalate to Dose Level 3 following the dose escalation schedule. Dose Level 3 will be administered via IV at 15 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8. Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5. Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.
- id
- BG002
- title
- Dose Level 3
- description
- If Dose Level 3 is tolerated, the study will escalate to Dose Level 4 following the dose escalation schedule. Dose Level 4 will be administered via IV at 25 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus will not be escalated beyond Dose Level 4. Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8. Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5. Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.
- id
- BG003
- title
- Dose Level 4
- description
- Total of all reporting groups
- id
- BG004
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 16
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 6
- title
- Female
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 10
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 8
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 7
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 1
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 10
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 4
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 2
- title
- Canada
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 13
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 1
- title
- Australia
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- # of prior therapies : 1 prior therapy
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 3
- title
- # of prior therapies : 2 prior therapies
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 5
- title
- # of prior therapies : 3 prior therapies
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- # of prior therapies : 4 prior therapies
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 4
- title
- # of prior therapies : 5 prior therapies
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- # of prior therapies : 6 prior therapies
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 3
- title
- # of prior therapies : 7 prior therapies
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 8
- title
- Prior transplant : Yes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 7
- title
- Prior transplant : No
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 4
- title
- Prior CAR-T cell therapy : Yes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 11
- title
- Prior CAR-T cell therapy : No
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Total number of patients that were enrolled onto the study
- title
- Prior Therapy Regimens
- unit Of Measure
- Participants
- population Description
- Number of patients who were enrolled onto the study
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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