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NCT02257242 · FLOW

Participant flow

Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma · Source last updated 2023-02-09

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

groups
  1. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG000
    title
    Vincristine Sulfate Liposome Injection: 1.8 mg/m^2
  2. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG001
    title
    Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
  3. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG002
    title
    Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
  4. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG003
    title
    Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
  5. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG004
    title
    Vincristine Sulfate Liposome Injection: 2.10 mg/m^2
  6. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG005
    title
    Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
  7. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG006
    title
    Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
  8. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG007
    title
    Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
  9. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG008
    title
    Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      1 subject removed from study before any treatment due to temporary unavailability of study drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG000
    title
    Vincristine Sulfate Liposome Injection: 1.8 mg/m^2
  2. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG001
    title
    Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
  3. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG002
    title
    Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
  4. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG003
    title
    Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
  5. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG004
    title
    Vincristine Sulfate Liposome Injection: 2.10 mg/m^2
  6. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG005
    title
    Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
  7. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG006
    title
    Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
  8. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG007
    title
    Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
  9. description
    Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    id
    FG008
    title
    Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      1 subject removed from study before any treatment due to temporary unavailability of study drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice