NCT02642965 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- COURSE 1: Patients receive cytarabine IT on day 0 and at day 28-30 or up to 7 days prior to day 1 of course 2, and liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5. Patients with CNS1 receive no further CNS-directed therapy in course 1. Patients with CNS2 disease may receive additional 4-6 doses of cytarabine IT twice weekly starting 48 hours after the third dose of liposome-encapsulated daunorubicin-cytarabine until CNS is clear at the discretion of the investigator. Patients meeting criteria for CR, CRp, and CRi may proceed to course 2. COURSE 2: Patients receive filgrastim on days 1-5 and then on day 15 until blood count recovery, and fludarabine phosphate IV over 30 minutes and high-dose cytarabine IV over 1-3 hours QD on days 1-5.
- id
- FG000
- title
- Treatment (CPX-351 and FLAG)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 9
- type
- Physician Decision
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 38
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 25
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 13
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- COURSE 1: Patients receive cytarabine IT on day 0 and at day 28-30 or up to 7 days prior to day 1 of course 2, and liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5. Patients with CNS1 receive no further CNS-directed therapy in course 1. Patients with CNS2 disease may receive additional 4-6 doses of cytarabine IT twice weekly starting 48 hours after the third dose of liposome-encapsulated daunorubicin-cytarabine until CNS is clear at the discretion of the investigator. Patients meeting criteria for CR, CRp, and CRi may proceed to course 2. COURSE 2: Patients receive filgrastim on days 1-5 and then on day 15 until blood count recovery, and fludarabine phosphate IV over 30 minutes and high-dose cytarabine IV over 1-3 hours QD on days 1-5.
- id
- FG000
- title
- Treatment (CPX-351 and FLAG)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 9
- type
- Physician Decision
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 38
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 25
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 13
- type
- NOT COMPLETED
- title
- Overall Study
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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