TriangleNCT02467270 · OUTCOME
Kaplan-Meier Estimate of Duration of Response (DOR) of <=1% BCR-ABL1 IS (MR2) at Months 12 and 24
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
- 12 and 24 months after the first dose of study treatment
What was measured
DOR (≤1% BCR-ABL1IS) is defined as interval between first assessment at which criteria for ≤1% BCR-ABL1IS are met until earliest date at which loss of ≤1% BCR-ABL1IS occurs, or criteria for progression accelerated phase (AP) or blast Phase (BP) of chronic myeloid leukemia (CML) are met. Loss of ≤1% BCR-ABL1IS is an increase to \>1% of BCR-ABL1IS. Progression to AP: ≥15% and \<30% blasts in peripheral blood or bone marrow or ≥20% basophils in peripheral blood or bone marrow or ≥30% blasts + promyelocytes in peripheral blood or bone marrow (but \<30% blasts) or \<100\*109 platelets per liter in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to BP: ≥30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly. Kaplan-Meier method was used for analysis of percentage of participants who achieved DOR of 12 and 24 months.
Analysis population: ITT Population included all participants who were randomized and for whom BCR-ABL1IS could be measured (i.e., participants who had the b2a2/b3a2 transcript type), regardless of whether they received the assigned study drug. Overall number of participants analyzed is the number of participants with MR2. Number analyzed is the number of participants with data available for analysis at the specified time point.
Groups in this outcome
Treatment Period: Cohort A: Ponatinib 45 mg
Participants received ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
Treatment Period: Cohort B: Ponatinib 30 mg
Participants received ponatinib 30 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
Treatment Period: Cohort C: Ponatinib 15 mg
Participants received ponatinib 15 mg orally once daily in each 28-day cycle.
| Group | Source count |
|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 56 |
| Treatment Period: Cohort B: Ponatinib 30 mg | 38 |
| Treatment Period: Cohort C: Ponatinib 15 mg | 36 |
Reported measurements
Month 12
| Group | Source count |
|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 52 |
| Treatment Period: Cohort B: Ponatinib 30 mg | 35 |
| Treatment Period: Cohort C: Ponatinib 15 mg | 33 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 79.13 | Not reported | 64.5 | 88.3 | Not reported |
| Treatment Period: Cohort B: Ponatinib 30 mg | 79.20 | Not reported | 61.2 | 89.5 | Not reported |
| Treatment Period: Cohort C: Ponatinib 15 mg | 90.10 | Not reported | 72.4 | 96.7 | Not reported |
Month 24
| Group | Source count |
|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 56 |
| Treatment Period: Cohort B: Ponatinib 30 mg | 38 |
| Treatment Period: Cohort C: Ponatinib 15 mg | 36 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Period: Cohort A: Ponatinib 45 mg | 73.89 | Not reported | 59.9 | 83.6 | Not reported |
| Treatment Period: Cohort B: Ponatinib 30 mg | 77.91 | Not reported | 60.6 | 88.3 | Not reported |
| Treatment Period: Cohort C: Ponatinib 15 mg | 88.31 | Not reported | 71.8 | 95.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 64.5
- upper Limit
- 88.3
- value
- 79.13
- group Id
- OG001
- lower Limit
- 61.2
- upper Limit
- 89.5
- value
- 79.20
- group Id
- OG002
- lower Limit
- 72.4
- upper Limit
- 96.7
- value
- 90.10
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 33
- units
- Participants
- title
- Month 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 59.9
- upper Limit
- 83.6
- value
- 73.89
- group Id
- OG001
- lower Limit
- 60.6
- upper Limit
- 88.3
- value
- 77.91
- group Id
- OG002
- lower Limit
- 71.8
- upper Limit
- 95.4
- value
- 88.31
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 36
- units
- Participants
- title
- Month 24
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 36
- units
- Participants
- description
- DOR (≤1% BCR-ABL1IS) is defined as interval between first assessment at which criteria for ≤1% BCR-ABL1IS are met until earliest date at which loss of ≤1% BCR-ABL1IS occurs, or criteria for progression accelerated phase (AP) or blast Phase (BP) of chronic myeloid leukemia (CML) are met. Loss of ≤1% BCR-ABL1IS is an increase to \>1% of BCR-ABL1IS. Progression to AP: ≥15% and \<30% blasts in peripheral blood or bone marrow or ≥20% basophils in peripheral blood or bone marrow or ≥30% blasts + promyelocytes in peripheral blood or bone marrow (but \<30% blasts) or \<100\*109 platelets per liter in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to BP: ≥30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly. Kaplan-Meier method was used for analysis of percentage of participants who achieved DOR of 12 and 24 months.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
- id
- OG000
- title
- Treatment Period: Cohort A: Ponatinib 45 mg
- description
- Participants received ponatinib 30 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
- id
- OG001
- title
- Treatment Period: Cohort B: Ponatinib 30 mg
- description
- Participants received ponatinib 15 mg orally once daily in each 28-day cycle.
- id
- OG002
- title
- Treatment Period: Cohort C: Ponatinib 15 mg
- param Type
- NUMBER
- population Description
- ITT Population included all participants who were randomized and for whom BCR-ABL1IS could be measured (i.e., participants who had the b2a2/b3a2 transcript type), regardless of whether they received the assigned study drug. Overall number of participants analyzed is the number of participants with MR2. Number analyzed is the number of participants with data available for analysis at the specified time point.
- reporting Status
- POSTED
- time Frame
- 12 and 24 months after the first dose of study treatment
- title
- Kaplan-Meier Estimate of Duration of Response (DOR) of <=1% BCR-ABL1 IS (MR2) at Months 12 and 24
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice