NCT03462719 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
- id
- FG000
- title
- Treatment Arm A (Ibrutinib + Venetoclax)
- description
- Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mgs intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is of 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
- id
- FG001
- title
- Treatment Arm B (Chlorambucil + Obinutuzumab)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 3
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 87
- group Id
- FG001
- num Subjects
- 72
- type
- Ongoing
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 106
- group Id
- FG001
- num Subjects
- 105
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 15
- group Id
- FG001
- num Subjects
- 30
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 91
- group Id
- FG001
- num Subjects
- 75
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
- id
- FG000
- title
- Treatment Arm A (Ibrutinib + Venetoclax)
- description
- Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mgs intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is of 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
- id
- FG001
- title
- Treatment Arm B (Chlorambucil + Obinutuzumab)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 3
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 87
- group Id
- FG001
- num Subjects
- 72
- type
- Ongoing
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 106
- group Id
- FG001
- num Subjects
- 105
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 15
- group Id
- FG001
- num Subjects
- 30
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 91
- group Id
- FG001
- num Subjects
- 75
- type
- NOT COMPLETED
- title
- Overall Study
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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