TriangleNCT02257242 · OUTCOME
Response Rate
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
- Up to 6 cycles of treatment (approximately 6 months)
What was measured
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Groups in this outcome
Vincristine Sulfate Liposome Injection: 1.8 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
Vincristine Sulfate Liposome Injection: 2.10 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
| Group | Source count |
|---|---|
| Vincristine Sulfate Liposome Injection: 1.8 mg/m^2 | 1 |
| Vincristine Sulfate Liposome Injection: 1.95 mg/m^2 | 1 |
| Vincristine Sulfate Liposome Injection: 1.98 mg/m^2 | 1 |
| Vincristine Sulfate Liposome Injection: 2.04 mg/m^2 | 2 |
| Vincristine Sulfate Liposome Injection: 2.10 mg/m^2 | 1 |
| Vincristine Sulfate Liposome Injection: 2.14 mg/m^2 | 1 |
| Vincristine Sulfate Liposome Injection: 2.19 mg/m^2 | 1 |
| Vincristine Sulfate Liposome Injection: 2.22 mg/m^2 | 1 |
| Vincristine Sulfate Liposome Injection: 2.24 mg/m^2 | 1 |
Reported measurements
Source class 1
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vincristine Sulfate Liposome Injection: 1.8 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 1.95 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 1.98 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.04 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.10 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.14 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.19 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.22 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.24 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vincristine Sulfate Liposome Injection: 1.8 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 1.95 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 1.98 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.04 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.10 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.14 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.19 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.22 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.24 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vincristine Sulfate Liposome Injection: 1.8 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 1.95 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 1.98 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.04 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.10 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.14 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.19 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.22 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Vincristine Sulfate Liposome Injection: 2.24 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- title
- Complete Response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Partial Response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Stable Disease
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- units
- Participants
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
- groups
- description
- Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
- id
- OG000
- title
- Vincristine Sulfate Liposome Injection: 1.8 mg/m^2
- description
- Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
- id
- OG001
- title
- Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
- description
- Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
- id
- OG002
- title
- Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
- description
- Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
- id
- OG003
- title
- Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
- description
- Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
- id
- OG004
- title
- Vincristine Sulfate Liposome Injection: 2.10 mg/m^2
- description
- Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
- id
- OG005
- title
- Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
- description
- Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
- id
- OG006
- title
- Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
- description
- Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
- id
- OG007
- title
- Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
- description
- Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
- id
- OG008
- title
- Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 6 cycles of treatment (approximately 6 months)
- title
- Response Rate
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice