TriangleNCT00777036 · OUTCOME
Major Molecular Response (MMR) Rate up to 7.5 Years
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
- 90 months
What was measured
Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time qPCR. MMR for participants with the p210 BCR-ABL transcript variant is defined according to the recommendations of Hughes et al. as a ratio BCR-ABL/ABL \<= 10-3 or 0.1% on the international scale proposed by the authors. The standardized baseline, as established in the IRIS trial, is taken to represent 100% on the international scale and a 3-log reduction in ratio (BCR-ABL transcripts/ABL or BCR) from the standardized baseline (MMR) is fixed at 0.1%. In this study, ABL or other housekeeping gene, will be used as the control-gene. For a participant with the p190 BCR-ABL transcript variant, on-study assessments will be compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to \< 0.1% or a 3-log reduction from baseline will be considered an MMR. The percentage of treated participants with MMR is reported by arm.
Analysis population: All treated participants
Groups in this outcome
Cohort 1
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Cohort 2
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Cohort 3
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Cohort 3b
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
| Group | Source count |
|---|---|
| Cohort 1 | 29 |
| Cohort 2 | 17 |
| Cohort 3 | 84 |
| Cohort 3a | 51 |
| Cohort 3b | 33 |
Reported measurements
12 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 41.4 | Not reported | 23.5 | 61.1 | Not reported |
| Cohort 2 | 29.4 | Not reported | 10.3 | 56.0 | Not reported |
| Cohort 3 | 52.4 | Not reported | 41.2 | 63.4 | Not reported |
| Cohort 3a | 56.9 | Not reported | 42.2 | 70.7 | Not reported |
| Cohort 3b | 45.5 | Not reported | 28.1 | 63.6 | Not reported |
24 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 55.2 | Not reported | 35.7 | 73.6 | Not reported |
| Cohort 2 | 29.4 | Not reported | 10.3 | 56.0 | Not reported |
| Cohort 3 | 70.2 | Not reported | 59.3 | 79.7 | Not reported |
| Cohort 3a | 74.5 | Not reported | 60.4 | 85.7 | Not reported |
| Cohort 3b | 63.6 | Not reported | 45.1 | 79.6 | Not reported |
36 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 62.1 | Not reported | 42.3 | 79.3 | Not reported |
| Cohort 2 | 29.4 | Not reported | 10.3 | 56.0 | Not reported |
| Cohort 3 | 77.4 | Not reported | 67.0 | 85.8 | Not reported |
| Cohort 3a | 82.4 | Not reported | 69.1 | 91.6 | Not reported |
| Cohort 3b | 69.7 | Not reported | 51.3 | 84.4 | Not reported |
48 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 62.1 | Not reported | 42.3 | 79.3 | Not reported |
| Cohort 2 | 29.4 | Not reported | 10.3 | 56.0 | Not reported |
| Cohort 3 | 82.1 | Not reported | 72.3 | 89.6 | Not reported |
| Cohort 3a | 88.2 | Not reported | 76.1 | 95.6 | Not reported |
| Cohort 3b | 72.7 | Not reported | 54.5 | 86.7 | Not reported |
60 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 65.5 | Not reported | 45.7 | 82.1 | Not reported |
| Cohort 2 | 29.4 | Not reported | 10.3 | 56.0 | Not reported |
| Cohort 3 | 83.3 | Not reported | 73.6 | 90.6 | Not reported |
| Cohort 3a | 90.2 | Not reported | 78.6 | 96.7 | Not reported |
| Cohort 3b | 72.7 | Not reported | 54.5 | 86.7 | Not reported |
72 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 65.5 | Not reported | 45.7 | 82.1 | Not reported |
| Cohort 2 | 29.4 | Not reported | 10.3 | 56.0 | Not reported |
| Cohort 3 | 84.5 | Not reported | 75.0 | 91.5 | Not reported |
| Cohort 3a | 90.2 | Not reported | 78.6 | 96.7 | Not reported |
| Cohort 3b | 75.8 | Not reported | 57.7 | 88.9 | Not reported |
84 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 65.5 | Not reported | 45.7 | 82.1 | Not reported |
| Cohort 2 | 29.4 | Not reported | 10.3 | 56.0 | Not reported |
| Cohort 3 | 84.5 | Not reported | 75.0 | 91.5 | Not reported |
| Cohort 3a | 90.2 | Not reported | 78.6 | 96.7 | Not reported |
| Cohort 3b | 75.8 | Not reported | 57.7 | 88.9 | Not reported |
90 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 69.0 | Not reported | 49.2 | 84.7 | Not reported |
| Cohort 2 | 29.4 | Not reported | 10.3 | 56.0 | Not reported |
| Cohort 3 | 84.5 | Not reported | 75.0 | 91.5 | Not reported |
| Cohort 3a | 90.2 | Not reported | 78.6 | 96.7 | Not reported |
| Cohort 3b | 75.8 | Not reported | 57.7 | 88.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.5
- upper Limit
- 61.1
- value
- 41.4
- group Id
- OG001
- lower Limit
- 10.3
- upper Limit
- 56.0
- value
- 29.4
- group Id
- OG002
- lower Limit
- 41.2
- upper Limit
- 63.4
- value
- 52.4
- group Id
- OG003
- lower Limit
- 42.2
- upper Limit
- 70.7
- value
- 56.9
- group Id
- OG004
- lower Limit
- 28.1
- upper Limit
- 63.6
- value
- 45.5
- title
- 12 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.7
- upper Limit
- 73.6
- value
- 55.2
- group Id
- OG001
- lower Limit
- 10.3
- upper Limit
- 56.0
- value
- 29.4
- group Id
- OG002
- lower Limit
- 59.3
- upper Limit
- 79.7
- value
- 70.2
- group Id
- OG003
- lower Limit
- 60.4
- upper Limit
- 85.7
- value
- 74.5
- group Id
- OG004
- lower Limit
- 45.1
- upper Limit
- 79.6
- value
- 63.6
- title
- 24 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 42.3
- upper Limit
- 79.3
- value
- 62.1
- group Id
- OG001
- lower Limit
- 10.3
- upper Limit
- 56.0
- value
- 29.4
- group Id
- OG002
- lower Limit
- 67.0
- upper Limit
- 85.8
- value
- 77.4
- group Id
- OG003
- lower Limit
- 69.1
- upper Limit
- 91.6
- value
- 82.4
- group Id
- OG004
- lower Limit
- 51.3
- upper Limit
- 84.4
- value
- 69.7
- title
- 36 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 42.3
- upper Limit
- 79.3
- value
- 62.1
- group Id
- OG001
- lower Limit
- 10.3
- upper Limit
- 56.0
- value
- 29.4
- group Id
- OG002
- lower Limit
- 72.3
- upper Limit
- 89.6
- value
- 82.1
- group Id
- OG003
- lower Limit
- 76.1
- upper Limit
- 95.6
- value
- 88.2
- group Id
- OG004
- lower Limit
- 54.5
- upper Limit
- 86.7
- value
- 72.7
- title
- 48 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45.7
- upper Limit
- 82.1
- value
- 65.5
- group Id
- OG001
- lower Limit
- 10.3
- upper Limit
- 56.0
- value
- 29.4
- group Id
- OG002
- lower Limit
- 73.6
- upper Limit
- 90.6
- value
- 83.3
- group Id
- OG003
- lower Limit
- 78.6
- upper Limit
- 96.7
- value
- 90.2
- group Id
- OG004
- lower Limit
- 54.5
- upper Limit
- 86.7
- value
- 72.7
- title
- 60 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45.7
- upper Limit
- 82.1
- value
- 65.5
- group Id
- OG001
- lower Limit
- 10.3
- upper Limit
- 56.0
- value
- 29.4
- group Id
- OG002
- lower Limit
- 75.0
- upper Limit
- 91.5
- value
- 84.5
- group Id
- OG003
- lower Limit
- 78.6
- upper Limit
- 96.7
- value
- 90.2
- group Id
- OG004
- lower Limit
- 57.7
- upper Limit
- 88.9
- value
- 75.8
- title
- 72 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45.7
- upper Limit
- 82.1
- value
- 65.5
- group Id
- OG001
- lower Limit
- 10.3
- upper Limit
- 56.0
- value
- 29.4
- group Id
- OG002
- lower Limit
- 75.0
- upper Limit
- 91.5
- value
- 84.5
- group Id
- OG003
- lower Limit
- 78.6
- upper Limit
- 96.7
- value
- 90.2
- group Id
- OG004
- lower Limit
- 57.7
- upper Limit
- 88.9
- value
- 75.8
- title
- 84 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 49.2
- upper Limit
- 84.7
- value
- 69.0
- group Id
- OG001
- lower Limit
- 10.3
- upper Limit
- 56.0
- value
- 29.4
- group Id
- OG002
- lower Limit
- 75.0
- upper Limit
- 91.5
- value
- 84.5
- group Id
- OG003
- lower Limit
- 78.6
- upper Limit
- 96.7
- value
- 90.2
- group Id
- OG004
- lower Limit
- 57.7
- upper Limit
- 88.9
- value
- 75.8
- title
- 90 months
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 84
- group Id
- OG003
- value
- 51
- group Id
- OG004
- value
- 33
- units
- Participants
- description
- Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time qPCR. MMR for participants with the p210 BCR-ABL transcript variant is defined according to the recommendations of Hughes et al. as a ratio BCR-ABL/ABL \<= 10-3 or 0.1% on the international scale proposed by the authors. The standardized baseline, as established in the IRIS trial, is taken to represent 100% on the international scale and a 3-log reduction in ratio (BCR-ABL transcripts/ABL or BCR) from the standardized baseline (MMR) is fixed at 0.1%. In this study, ABL or other housekeeping gene, will be used as the control-gene. For a participant with the p190 BCR-ABL transcript variant, on-study assessments will be compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to \< 0.1% or a 3-log reduction from baseline will be considered an MMR. The percentage of treated participants with MMR is reported by arm.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
- id
- OG000
- title
- Cohort 1
- description
- Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
- id
- OG001
- title
- Cohort 2
- description
- Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
- id
- OG002
- title
- Cohort 3
- description
- Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
- id
- OG003
- title
- Cohort 3a
- description
- Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
- id
- OG004
- title
- Cohort 3b
- param Type
- NUMBER
- population Description
- All treated participants
- reporting Status
- POSTED
- time Frame
- 90 months
- title
- Major Molecular Response (MMR) Rate up to 7.5 Years
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice