TriangleNCT02034110 · OUTCOME
Overall Response Rate (ORR) in the Hairy Cell Leukemia (HCL) Cohort
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
- From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
What was measured
Overall Response Rate (ORR) was defined as the percentage of participants with CR +/- minimal residual disease \[MRD\], PR by investigator assessment as defined by the Consensus Resolution Criteria adapted from the National Comprehensive Cancer Network (NCCN) guidelines. Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
Analysis population: ITT/Evaluable population - Primary and expansion cohort combined
Groups in this outcome
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
| Group | Source count |
|---|---|
| Hairy Cell Leukemia (HCL) | 55 |
Reported measurements
Investigator assessment @ up to 78 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Hairy Cell Leukemia (HCL) | 89 | Not reported | 77.8 | 95.9 | Not reported |
Investigator assessment @ up to 92 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Hairy Cell Leukemia (HCL) | 89 | Not reported | 77.8 | 95.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 77.8
- upper Limit
- 95.9
- value
- 89
- title
- Investigator assessment @ up to 78 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 77.8
- upper Limit
- 95.9
- value
- 89
- title
- Investigator assessment @ up to 92 months
- denoms
- counts
- group Id
- OG000
- value
- 55
- units
- Participants
- description
- Overall Response Rate (ORR) was defined as the percentage of participants with CR +/- minimal residual disease \[MRD\], PR by investigator assessment as defined by the Consensus Resolution Criteria adapted from the National Comprehensive Cancer Network (NCCN) guidelines. Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
- id
- OG000
- title
- Hairy Cell Leukemia (HCL)
- param Type
- NUMBER
- population Description
- ITT/Evaluable population - Primary and expansion cohort combined
- reporting Status
- POSTED
- time Frame
- From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
- title
- Overall Response Rate (ORR) in the Hairy Cell Leukemia (HCL) Cohort
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice