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NCT02257242 · OUTCOME

Maximum Tolerated Dose

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.

Measure
NUMBER
Unit
mg/m^2
Interval / dispersion
Not reported
Time frame
Up to 6 cycles of treatment (approximately 6 months)

What was measured

Determined as the median of the marginal posterior distribution using data from all available patients

Groups in this outcome

Dose-escalation Cohort

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose-escalation Cohort10

Reported measurements

Source class 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose-escalation Cohort2.24Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2.24
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Determined as the median of the marginal posterior distribution using data from all available patients
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
    OG000
    title
    Dose-escalation Cohort
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 6 cycles of treatment (approximately 6 months)
title
Maximum Tolerated Dose
type
PRIMARY
unit Of Measure
mg/m^2

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

Preserved source evidence · Not medical advice