TriangleNCT01445535 · OUTCOME
Number of Participants With a Response to Therapy
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
- Response assessments were performed after the fourth and sixth cycle of therapy, at therapy completion, and every 3 months for year 1, four months for year 2, 6 months for years 3-5, and annually thereafter, up to 5 years.
What was measured
Response was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete Remission was defined as the disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (for example lactate dehydrogenase (LDH)) definitely assignable to the lymphoma. Complete response unconfirmed was defined as a residual node greater than 1.5 cm, with a decrease by greater than 75 percent in the sum of the products of the perpendicular diameters (SPD) of all measured lymph nodes. Partial Response was defined as a ≥ 50% decreased in SPD of 6 largest dominant nodes or nodal masses. Relapsed disease was defined as the appearance of any new lesion or increase by ≥50% in the size of the previously identified sites. Progressive disease was defined as a ≥50% increase from nadir in the SPD.
Groups in this outcome
Cohort 1 - 3.4 mg/kg
3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
Cohort 2 - 4.8 mg/kg
4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
Cohort 3 - 8.5 mg/kg
8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
Cohort 4 - 15 mg/kg
15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
| Group | Source count |
|---|---|
| Cohort 1 - 3.4 mg/kg | 3 |
| Cohort 2 - 4.8 mg/kg | 3 |
| Cohort 3 - 8.5 mg/kg | 3 |
| Cohort 4 - 15 mg/kg | 6 |
Reported measurements
Complete Remission
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - 3.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 - 4.8 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 - 8.5 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 - 15 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
Complete Response Unconfirmed
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 - 4.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 - 8.5 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 - 15 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - 3.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 - 4.8 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 - 8.5 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 - 15 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Relapsed Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 - 4.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 - 8.5 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 - 15 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - 3.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 - 4.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 - 8.5 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 - 15 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 - 4.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 - 8.5 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 - 15 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 - 4.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 - 8.5 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 - 15 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- title
- Complete Remission
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Complete Response Unconfirmed
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Relapsed Disease
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- units
- Participants
- description
- Response was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete Remission was defined as the disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (for example lactate dehydrogenase (LDH)) definitely assignable to the lymphoma. Complete response unconfirmed was defined as a residual node greater than 1.5 cm, with a decrease by greater than 75 percent in the sum of the products of the perpendicular diameters (SPD) of all measured lymph nodes. Partial Response was defined as a ≥ 50% decreased in SPD of 6 largest dominant nodes or nodal masses. Relapsed disease was defined as the appearance of any new lesion or increase by ≥50% in the size of the previously identified sites. Progressive disease was defined as a ≥50% increase from nadir in the SPD.
- groups
- description
- 3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
- id
- OG000
- title
- Cohort 1 - 3.4 mg/kg
- description
- 4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
- id
- OG001
- title
- Cohort 2 - 4.8 mg/kg
- description
- 8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
- id
- OG002
- title
- Cohort 3 - 8.5 mg/kg
- description
- 15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
- id
- OG003
- title
- Cohort 4 - 15 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Response assessments were performed after the fourth and sixth cycle of therapy, at therapy completion, and every 3 months for year 1, four months for year 2, 6 months for years 3-5, and annually thereafter, up to 5 years.
- title
- Number of Participants With a Response to Therapy
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice