TriangleNCT02435849 · OUTCOME
Percentage of Participants With Best Overall Response (BOR) of CR or CRi With Minimal Residue Disease (MRD) Negative Bone Marrow From US Manufacturing Facility as Per IRC in the Main Cohort Only (Key Secondary)
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
- 3 months after tisagenlecleucel administration
What was measured
These are the percentage of participants who achieved Best Overall Response (BOR) of complete response (CR) or complete response with incomplete blood count recovery (CRi) with an MRD-negative bone marrow by central analysis using flow cytometry among participants who received tisagenlecleucel from US manufacturing facilities only, by IRC assessment.
Analysis population: FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel from US manufacturing facilities.
Groups in this outcome
Main Cohort: Single Dose of CTL019
Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).
| Group | Source count |
|---|---|
| Main Cohort: Single Dose of CTL019 | 67 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Cohort: Single Dose of CTL019 | 82.1 | Not reported | 70.8 | 90.4 | Not reported |
Source statistical analyses
- group Ids
- OG000
- non Inferiority Comment
- testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%
- non Inferiority Type
- OTHER
- p Value
- <.0001
- statistical Method
- Clopper-Pearson
Complete source fields
- analyses
- group Ids
- OG000
- non Inferiority Comment
- testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%
- non Inferiority Type
- OTHER
- p Value
- <.0001
- statistical Method
- Clopper-Pearson
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 70.8
- upper Limit
- 90.4
- value
- 82.1
- denoms
- counts
- group Id
- OG000
- value
- 67
- units
- Participants
- description
- These are the percentage of participants who achieved Best Overall Response (BOR) of complete response (CR) or complete response with incomplete blood count recovery (CRi) with an MRD-negative bone marrow by central analysis using flow cytometry among participants who received tisagenlecleucel from US manufacturing facilities only, by IRC assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).
- id
- OG000
- title
- Main Cohort: Single Dose of CTL019
- param Type
- NUMBER
- population Description
- FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel from US manufacturing facilities.
- reporting Status
- POSTED
- time Frame
- 3 months after tisagenlecleucel administration
- title
- Percentage of Participants With Best Overall Response (BOR) of CR or CRi With Minimal Residue Disease (MRD) Negative Bone Marrow From US Manufacturing Facility as Per IRC in the Main Cohort Only (Key Secondary)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice