TriangleNCT02658968 · OUTCOME
Number of Participants With DLTs to Determine the MTD
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 12 weeks
What was measured
To determine the MTD of Betalutin that can be administered to DBLCL patients with lilotomab. The MTD was the highest dose at which less than two out of six participants experienced a dose limiting toxicity (DLT) defined as: * Haematologic toxicity: * Grade 4 neutropenia observed for greater than 7 days' duration * Grade 4 thrombocytopenia observed for greater than 7 days' duration * Grade 3 or 4 neutropenia associated with fever (≥38.5°C) of any duration * Grade 3 or 4 thrombocytopenia with bleeding * Thrombocytopenia with any requirement for more than one platelet transfusion before recovering to Grade 1 or less * Grade 4 anaemia, unexplained by underlying disease * Non-haematologic toxicity: * Grade 3 nausea/vomiting/diarrhoea lasting longer than 72 hours despite maximal care or Grade 4 * Any other Grade 3 or 4 non-haematologic toxicities * Any Grade 3 or 4 electrolyte abnormalities that do not resolve to Grade 1 or baseline within 24 hours
Groups in this outcome
60/10
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing.
100/10
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
100/15
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
100/20
Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
| Group | Source count |
|---|---|
| 60/10 | 3 |
| 100/10 | 3 |
| 100/15 | 3 |
| 100/20 | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 60/10 | 0 | Not reported | Not reported | Not reported | Not reported |
| 100/10 | 0 | Not reported | Not reported | Not reported | Not reported |
| 100/15 | 0 | Not reported | Not reported | Not reported | Not reported |
| 100/20 | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 7
- units
- Participants
- description
- To determine the MTD of Betalutin that can be administered to DBLCL patients with lilotomab. The MTD was the highest dose at which less than two out of six participants experienced a dose limiting toxicity (DLT) defined as: * Haematologic toxicity: * Grade 4 neutropenia observed for greater than 7 days' duration * Grade 4 thrombocytopenia observed for greater than 7 days' duration * Grade 3 or 4 neutropenia associated with fever (≥38.5°C) of any duration * Grade 3 or 4 thrombocytopenia with bleeding * Thrombocytopenia with any requirement for more than one platelet transfusion before recovering to Grade 1 or less * Grade 4 anaemia, unexplained by underlying disease * Non-haematologic toxicity: * Grade 3 nausea/vomiting/diarrhoea lasting longer than 72 hours despite maximal care or Grade 4 * Any other Grade 3 or 4 non-haematologic toxicities * Any Grade 3 or 4 electrolyte abnormalities that do not resolve to Grade 1 or baseline within 24 hours
- groups
- description
- Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing.
- id
- OG000
- title
- 60/10
- description
- Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
- id
- OG001
- title
- 100/10
- description
- Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
- id
- OG002
- title
- 100/15
- description
- Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
- id
- OG003
- title
- 100/20
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 12 weeks
- title
- Number of Participants With DLTs to Determine the MTD
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice