TriangleNCT01332968 · OUTCOME
Overall Response (Overall Study Population), Investigator-Assessed
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants with event
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to end of induction period (up to approximately 7 months)
What was measured
Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as \>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \>/= 50%; Overall Response (OR) = CR + PR.
Analysis population: The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.
Groups in this outcome
Rituximab+Chemotherapy
Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Obinutuzumab+Chemotherapy
Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
| Group | Source count |
|---|---|
| Rituximab+Chemotherapy | 699 |
| Obinutuzumab+Chemotherapy | 702 |
Reported measurements
Without PET
| Group | Source count |
|---|---|
| Rituximab+Chemotherapy | 599 |
| Obinutuzumab+Chemotherapy | 613 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab+Chemotherapy | 85.7 | Not reported | Not reported | Not reported | Not reported |
| Obinutuzumab+Chemotherapy | 87.3 | Not reported | Not reported | Not reported | Not reported |
With PET
| Group | Source count |
|---|---|
| Rituximab+Chemotherapy | 270 |
| Obinutuzumab+Chemotherapy | 274 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab+Chemotherapy | 81.8 | Not reported | Not reported | Not reported | Not reported |
| Obinutuzumab+Chemotherapy | 85.4 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -2.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.3
- group Description
- Without PET
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.33
- param Type
- Absolute difference in %
- param Value
- 1.6
- statistical Method
- Log Rank
- ci Lower Limit
- -2.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 9.4
- group Description
- With PET
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.17
- param Type
- Absolute difference in %
- param Value
- 3.5
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- -2.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.3
- group Description
- Without PET
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.33
- param Type
- Absolute difference in %
- param Value
- 1.6
- statistical Method
- Log Rank
- ci Lower Limit
- -2.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 9.4
- group Description
- With PET
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.17
- param Type
- Absolute difference in %
- param Value
- 3.5
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- value
- 85.7
- group Id
- OG001
- value
- 87.3
- denoms
- counts
- group Id
- OG000
- value
- 599
- group Id
- OG001
- value
- 613
- units
- Participants
- title
- Without PET
- categories
- measurements
- group Id
- OG000
- value
- 81.8
- group Id
- OG001
- value
- 85.4
- denoms
- counts
- group Id
- OG000
- value
- 270
- group Id
- OG001
- value
- 274
- units
- Participants
- title
- With PET
- denoms
- counts
- group Id
- OG000
- value
- 699
- group Id
- OG001
- value
- 702
- units
- Participants
- description
- Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as \>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \>/= 50%; Overall Response (OR) = CR + PR.
- groups
- description
- Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
- id
- OG000
- title
- Rituximab+Chemotherapy
- description
- Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
- id
- OG001
- title
- Obinutuzumab+Chemotherapy
- param Type
- NUMBER
- population Description
- The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of induction period (up to approximately 7 months)
- title
- Overall Response (Overall Study Population), Investigator-Assessed
- type
- SECONDARY
- unit Of Measure
- percentage of participants with event
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice