TriangleNCT03679624 · OUTCOME
Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Standard Deviation
- Time frame
- 3 months
What was measured
Measured from time of study drug administration to progression or death, measured in months.
Analysis population: Cohort A participant did not complete enough cycles to evaluate for response. 0 subjects were enrolled in Cohort B.
Groups in this outcome
Cohort A - Ibrutinib Naive
Cohort A will consist of subjects who are ibrutinib naïve and appropriate for ibrutinib based treatment. Treatment naïve subjects will be eligible to enroll in this cohort. All subjects in this cohort will receive ibrutinib plus daratumumab Ibrutinib: Ibrutinib, 420mg orally, once daily Daratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.
Cohort B - Ibrutinib Response Plateau
Cohort B will consist of subjects who have had at least 6 months of exposure to single agent ibrutinib and who have demonstrated an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed \<15% from the previous mark. All subjects in this cohort will receive ibrutinib plus daratumumab Ibrutinib: Ibrutinib, 420mg orally, once daily Daratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.
| Group | Source count |
|---|---|
| Cohort A - Ibrutinib Naive | 1 |
| Cohort B - Ibrutinib Response Plateau | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A - Ibrutinib Naive | NA | Not reported | Not reported | Not reported | lack of participants with events |
Complete source fields
- classes
- categories
- measurements
- comment
- lack of participants with events
- group Id
- OG000
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- Measured from time of study drug administration to progression or death, measured in months.
- dispersion Type
- Standard Deviation
- groups
- description
- Cohort A will consist of subjects who are ibrutinib naïve and appropriate for ibrutinib based treatment. Treatment naïve subjects will be eligible to enroll in this cohort. All subjects in this cohort will receive ibrutinib plus daratumumab Ibrutinib: Ibrutinib, 420mg orally, once daily Daratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.
- id
- OG000
- title
- Cohort A - Ibrutinib Naive
- description
- Cohort B will consist of subjects who have had at least 6 months of exposure to single agent ibrutinib and who have demonstrated an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed \<15% from the previous mark. All subjects in this cohort will receive ibrutinib plus daratumumab Ibrutinib: Ibrutinib, 420mg orally, once daily Daratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.
- id
- OG001
- title
- Cohort B - Ibrutinib Response Plateau
- param Type
- MEDIAN
- population Description
- Cohort A participant did not complete enough cycles to evaluate for response. 0 subjects were enrolled in Cohort B.
- reporting Status
- POSTED
- time Frame
- 3 months
- title
- Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice