TriangleNCT01614197 · OUTCOME
Response Rate at the Completion of 1 Cycle of Study Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1 (a minimum of 4 weeks and a max of 8 weeks)
What was measured
CR = Complete remission defined as attainment of bone marrow with \<5% blasts with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil counts (ANC) \> or = to 500/uL and platelet count \> or = to 50,000 microliters) CRi = Complete remission with incomplete blood count recovery defined as attainment of bone marrow with \>5% blasts with no evidence of circulating blasts or extramedullary disease but insufficient recovery of ANC \< 500/uL or platelets \< 50,000 microliters PR = partial remission defined as complete disappearance of circulating blasts and achievement of 5-25% blasts if greater than 25% blasts originally without new sites of extramedullary disease and with recovery of ANC. SD = stable disease defined as not satisfying criteria for PD, or has recovery of ANC \> or = to 500/uL and fails to qualify for CR, CRi, or PR PD = progressive disease defined as an increase of at least 25% in bone marrow leukemic cells
Analysis population: All these analyses will be descriptive and exploratory and hypotheses generating in nature.
Groups in this outcome
Dose Level 1
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.
Dose Level 2
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.
Dose Level 3
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.
Dose Level 4
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.
| Group | Source count |
|---|---|
| Dose Level 1 | 3 |
| Dose Level 2 | 3 |
| Dose Level 3 | 6 |
| Dose Level 4 | 3 |
Reported measurements
Source class 1
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4 | 0 | Not reported | Not reported | Not reported | Not reported |
CRi
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4 | 1 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4 | 0 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4 | 1 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4 | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- CR
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- title
- CRi
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- PR
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- title
- SD
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- title
- PD
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 3
- units
- Participants
- description
- CR = Complete remission defined as attainment of bone marrow with \<5% blasts with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil counts (ANC) \> or = to 500/uL and platelet count \> or = to 50,000 microliters) CRi = Complete remission with incomplete blood count recovery defined as attainment of bone marrow with \>5% blasts with no evidence of circulating blasts or extramedullary disease but insufficient recovery of ANC \< 500/uL or platelets \< 50,000 microliters PR = partial remission defined as complete disappearance of circulating blasts and achievement of 5-25% blasts if greater than 25% blasts originally without new sites of extramedullary disease and with recovery of ANC. SD = stable disease defined as not satisfying criteria for PD, or has recovery of ANC \> or = to 500/uL and fails to qualify for CR, CRi, or PR PD = progressive disease defined as an increase of at least 25% in bone marrow leukemic cells
- 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
- OG000
- 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
- OG001
- 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
- OG002
- 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
- OG003
- title
- Dose Level 4
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All these analyses will be descriptive and exploratory and hypotheses generating in nature.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (a minimum of 4 weeks and a max of 8 weeks)
- title
- Response Rate at the Completion of 1 Cycle of Study Treatment
- type
- SECONDARY
- unit Of Measure
- Participants
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