TriangleNCT02911142 · OUTCOME
Response Rate of Participants With Active Multicentric Castleman Disease (MCD) Assessed by the National Cancer Institute (NCI) MCD Response Criteria Reported Along With a 90% Confidence Interval
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
- At end of treatment (after 18 weeks of treatment)
What was measured
Response rate is calculated by the percentage of participants with either a partial or complete response. Complete Response (CR) is full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to MCD, lasting at least 3 weeks. Partial Response (PR) is at least 50% of the abnormalities probably or definitely attributed to Kaposi sarcoma-associated herpesvirus (KSHV)-MCD must improve by the minimum amounts specified to attain PR (e.g., C-reactive protein reduction to ≤50% of baseline; and Hemoglobin increment 2g/dL not explained by transfusion).
Analysis population: 5/17 participants were analyzed because responses were only measured in participants with MCD.
Groups in this outcome
Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab
Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
| Group | Source count |
|---|---|
| Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab | 60 | Not reported | 19 | 92 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19
- upper Limit
- 92
- value
- 60
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- Response rate is calculated by the percentage of participants with either a partial or complete response. Complete Response (CR) is full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to MCD, lasting at least 3 weeks. Partial Response (PR) is at least 50% of the abnormalities probably or definitely attributed to Kaposi sarcoma-associated herpesvirus (KSHV)-MCD must improve by the minimum amounts specified to attain PR (e.g., C-reactive protein reduction to ≤50% of baseline; and Hemoglobin increment 2g/dL not explained by transfusion).
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
- id
- OG000
- title
- Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab
- param Type
- NUMBER
- population Description
- 5/17 participants were analyzed because responses were only measured in participants with MCD.
- reporting Status
- POSTED
- time Frame
- At end of treatment (after 18 weeks of treatment)
- title
- Response Rate of Participants With Active Multicentric Castleman Disease (MCD) Assessed by the National Cancer Institute (NCI) MCD Response Criteria Reported Along With a 90% Confidence Interval
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice