Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00281918 · FLOW

Participant flow

Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia · Source last updated 2013-09-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
    id
    FG000
    title
    Fludarabine+Cyclophosphamide (FC)
  2. description
    Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
    id
    FG001
    title
    Fludarabine+Cyclophosphamide+Rituximab (FCR)
periods
  1. milestones
    1. achievements
      1. comment
        Informed consent unavailable for 2 patients at time of analysis; intent-to-treat population was 407.
        group Id
        FG000
        num Subjects
        409
      2. comment
        Informed consent unavailable for 5 patients at time of analysis; intent-to-treat population was 403.
        group Id
        FG001
        num Subjects
        408
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        398
      2. group Id
        FG001
        num Subjects
        402
      type
      Safety Population; Received Study Drug
    3. achievements
      1. comment
        Completed all 6 cycles of study medication.
        group Id
        FG000
        num Subjects
        267
      2. comment
        Completed all 6 cycles of study medication.
        group Id
        FG001
        num Subjects
        300
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        142
      2. group Id
        FG001
        num Subjects
        108
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
    id
    FG000
    title
    Fludarabine+Cyclophosphamide (FC)
  2. description
    Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
    id
    FG001
    title
    Fludarabine+Cyclophosphamide+Rituximab (FCR)
periods
  1. milestones
    1. achievements
      1. comment
        Informed consent unavailable for 2 patients at time of analysis; intent-to-treat population was 407.
        group Id
        FG000
        num Subjects
        409
      2. comment
        Informed consent unavailable for 5 patients at time of analysis; intent-to-treat population was 403.
        group Id
        FG001
        num Subjects
        408
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        398
      2. group Id
        FG001
        num Subjects
        402
      type
      Safety Population; Received Study Drug
    3. achievements
      1. comment
        Completed all 6 cycles of study medication.
        group Id
        FG000
        num Subjects
        267
      2. comment
        Completed all 6 cycles of study medication.
        group Id
        FG001
        num Subjects
        300
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        142
      2. group Id
        FG001
        num Subjects
        108
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice