TriangleNCT01471782 · OUTCOME
Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant During Blinatumomab Induced Remission
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to the data cut-off date of 12 January 2015; Maximum duration on study was 24 months in phase 1 and 15 months for phase 2.
What was measured
The percentage of participants who received allogeneic hematopoietic stem cell transplantation (HSCT) while in remission due to treatment with blinatumomab during the first two cycles, and received no further anti-leukemic medication before HSCT.
Analysis population: Full analysis set
Groups in this outcome
Phase 1: Blinatumomab 5 µg/m²/Day
Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
Phase 1: Blinatumomab 15 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
Phase 1: Blinatumomab 30 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
Phase 1: Blinatumomab 15/30 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
Phase 1: Blinatumomab 5/15 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
Phase 2: Blinatumomab 5/15 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
Phase 1+2: Blinatumomab 5/15 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
| Group | Source count |
|---|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 5 |
| Phase 1: Blinatumomab 15 µg/m²/Day | 7 |
| Phase 1: Blinatumomab 30 µg/m²/Day | 5 |
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 6 |
| Phase 1: Blinatumomab 5/15 µg/m²/Day | 26 |
| Phase 2: Blinatumomab 5/15 µg/m²/Day | 44 |
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 70 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 20.0 | Not reported | 0.5 | 71.6 | Not reported |
| Phase 1: Blinatumomab 15 µg/m²/Day | 28.6 | Not reported | 3.7 | 71.0 | Not reported |
| Phase 1: Blinatumomab 30 µg/m²/Day | 20.0 | Not reported | 0.5 | 71.6 | Not reported |
| Phase 1: Blinatumomab 15/30 µg/m²/Day | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| Phase 1: Blinatumomab 5/15 µg/m²/Day | 30.8 | Not reported | 14.3 | 51.8 | Not reported |
| Phase 2: Blinatumomab 5/15 µg/m²/Day | 11.4 | Not reported | 3.8 | 24.6 | Not reported |
| Phase 1+2: Blinatumomab 5/15 µg/m²/Day | 18.6 | Not reported | 10.3 | 29.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 71.6
- value
- 20.0
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 71.0
- value
- 28.6
- group Id
- OG002
- lower Limit
- 0.5
- upper Limit
- 71.6
- value
- 20.0
- group Id
- OG003
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG004
- lower Limit
- 14.3
- upper Limit
- 51.8
- value
- 30.8
- group Id
- OG005
- lower Limit
- 3.8
- upper Limit
- 24.6
- value
- 11.4
- group Id
- OG006
- lower Limit
- 10.3
- upper Limit
- 29.7
- value
- 18.6
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 26
- group Id
- OG005
- value
- 44
- group Id
- OG006
- value
- 70
- units
- Participants
- description
- The percentage of participants who received allogeneic hematopoietic stem cell transplantation (HSCT) while in remission due to treatment with blinatumomab during the first two cycles, and received no further anti-leukemic medication before HSCT.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
- id
- OG000
- title
- Phase 1: Blinatumomab 5 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
- id
- OG001
- title
- Phase 1: Blinatumomab 15 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
- id
- OG002
- title
- Phase 1: Blinatumomab 30 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
- id
- OG003
- title
- Phase 1: Blinatumomab 15/30 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
- id
- OG004
- title
- Phase 1: Blinatumomab 5/15 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
- id
- OG005
- title
- Phase 2: Blinatumomab 5/15 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
- id
- OG006
- title
- Phase 1+2: Blinatumomab 5/15 µg/m²/Day
- param Type
- NUMBER
- population Description
- Full analysis set
- reporting Status
- POSTED
- time Frame
- Up to the data cut-off date of 12 January 2015; Maximum duration on study was 24 months in phase 1 and 15 months for phase 2.
- title
- Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant During Blinatumomab Induced Remission
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice