NCT02911142 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- 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
- FG000
- title
- Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Did not complete last cycle of EPOCH-R2 due to progressive disease.
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- Received specified dose
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- Underwent screening/staging
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- Evaluated for response
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- Off treatment
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- Off study
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- Disease progression on study
- achievements
- group Id
- FG000
- num Subjects
- 5
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Phase I - Safety & Tolerability
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Refused further treatment
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- Received specified dose
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- Evaluated for response
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- Off treatment
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- Off study
- achievements
- group Id
- FG000
- num Subjects
- 3
- type
- Disease progression on study
- achievements
- group Id
- FG000
- num Subjects
- 7
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 4
- type
- NOT COMPLETED
- title
- Phase II - Recommended Phase 2 Dose
Complete source fields
- 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
- FG000
- title
- Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Did not complete last cycle of EPOCH-R2 due to progressive disease.
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- Received specified dose
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- Underwent screening/staging
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- Evaluated for response
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- Off treatment
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- Off study
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- Disease progression on study
- achievements
- group Id
- FG000
- num Subjects
- 5
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Phase I - Safety & Tolerability
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Refused further treatment
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- Received specified dose
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- Evaluated for response
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- Off treatment
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- Off study
- achievements
- group Id
- FG000
- num Subjects
- 3
- type
- Disease progression on study
- achievements
- group Id
- FG000
- num Subjects
- 7
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 4
- type
- NOT COMPLETED
- title
- Phase II - Recommended Phase 2 Dose
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