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NCT00506857 · OUTCOME

Maximum Tolerated Dose (MTD)

Phase I/II Trial of Fludarabine Plus Busulfan and Allogeneic Progenitor Cell Support · Source last updated 2012-02-28

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

Measure
NUMBER
Unit
mg/kg
Interval / dispersion
Not reported
Time frame
1 month

What was measured

Continual reassessment method (four times a day) used to determine an MTD, with a target toxicity probability of 20%, where "toxicity" is defined as grade 3 or 4 conventional toxicity \[National Cancer Institute Common Toxicity Criteria (NCI-CTC)\]. Participant evaluation in a cohort with each modality is 30 days.

Analysis population: Analysis was per protocol.

Groups in this outcome

Busulfan + Fludarabine

Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m\^2 IV daily for 4 days.

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

Analysis denominator · Participants

GroupSource count
Busulfan + Fludarabine80

Reported measurements

Source class 1
Values in mg/kg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Fludarabine11.2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11.2
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    units
    Participants
description
Continual reassessment method (four times a day) used to determine an MTD, with a target toxicity probability of 20%, where "toxicity" is defined as grade 3 or 4 conventional toxicity \[National Cancer Institute Common Toxicity Criteria (NCI-CTC)\]. Participant evaluation in a cohort with each modality is 30 days.
groups
  1. description
    Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m\^2 IV daily for 4 days.
    id
    OG000
    title
    Busulfan + Fludarabine
param Type
NUMBER
population Description
Analysis was per protocol.
reporting Status
POSTED
time Frame
1 month
title
Maximum Tolerated Dose (MTD)
type
PRIMARY
unit Of Measure
mg/kg

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

Preserved source evidence · Not medical advice