TriangleNCT03384654 · OUTCOME
Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL
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
- 90% Confidence Interval
- Time frame
- End of Cycle 1 (that is, up to 28 days)
What was measured
Complete response based on the modified NCCN criteria was defined as: less than 5% blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets \>100\*10\^9 cells/L and ANC \>1.0\*10\^9 cells/L. This outcome measure was planned to be analyzed for specified arms only.
Analysis population: The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab.
Groups in this outcome
Cohort 2: T-Cell ALL (1-17 Years)
Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV infusion once on Day 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m\^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide IV 1 g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months).
Cohort 2: T-Cell ALL (18-30 Years)
Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months).
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months).
| Group | Source count |
|---|---|
| Cohort 2: T-Cell ALL (1-17 Years) | 24 |
| Cohort 2: T-Cell ALL (18-30 Years) | 5 |
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2: T-Cell ALL (1-17 Years) | 41.7 | Not reported | 24.6 | 60.3 | Not reported |
| Cohort 2: T-Cell ALL (18-30 Years) | 60.0 | Not reported | 18.9 | 92.4 | Not reported |
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 30.0 | Not reported | 8.7 | 60.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.6
- upper Limit
- 60.3
- value
- 41.7
- group Id
- OG001
- lower Limit
- 18.9
- upper Limit
- 92.4
- value
- 60.0
- group Id
- OG002
- lower Limit
- 8.7
- upper Limit
- 60.7
- value
- 30.0
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 10
- units
- Participants
- description
- Complete response based on the modified NCCN criteria was defined as: less than 5% blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets \>100\*10\^9 cells/L and ANC \>1.0\*10\^9 cells/L. This outcome measure was planned to be analyzed for specified arms only.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV infusion once on Day 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m\^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide IV 1 g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months).
- id
- OG000
- title
- Cohort 2: T-Cell ALL (1-17 Years)
- description
- Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months).
- id
- OG001
- title
- Cohort 2: T-Cell ALL (18-30 Years)
- description
- Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months).
- id
- OG002
- title
- Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
- param Type
- NUMBER
- population Description
- The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab.
- reporting Status
- POSTED
- time Frame
- End of Cycle 1 (that is, up to 28 days)
- title
- Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice