NCT01979536 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
- id
- FG000
- title
- Arm BV (Brentuximab Vedotin, Combination Chemotherapy)
- description
- COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
- id
- FG001
- title
- Arm CZ (Crizotinib, Combination Chemotherapy)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 3
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Refusal
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Relapse
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Study terminated by Sponsor
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Did not start treatment
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 68
- group Id
- FG001
- num Subjects
- 69
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 66
- group Id
- FG001
- num Subjects
- 61
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 8
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
- id
- FG000
- title
- Arm BV (Brentuximab Vedotin, Combination Chemotherapy)
- description
- COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
- id
- FG001
- title
- Arm CZ (Crizotinib, Combination Chemotherapy)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 3
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Refusal
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Relapse
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Study terminated by Sponsor
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Did not start treatment
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 68
- group Id
- FG001
- num Subjects
- 69
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 66
- group Id
- FG001
- num Subjects
- 61
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 8
- type
- NOT COMPLETED
- title
- Overall Study
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Preserved source evidence · Not medical advice
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