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NCT00943319 · OUTCOME

Maximum Tolerated Dose

Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies · Source last updated 2019-02-04

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

Measure
NUMBER
Unit
mmol-min/L
Interval / dispersion
Not reported
Time frame
5 years

What was measured

Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L.

Analysis population: The 36 patients refer to the phase I portion of the study only.

Groups in this outcome

Busulfan and Fludarabine

Intravenous busulfan (Busulfan®) in combination with fludarabine Busulfan: Daily intravenous dosing to target AVC Fludarabine: Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose. Campath: All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times). Stem Cell Transplant: Infusion of bone marrow and donors(related/ unrelated).

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 and Fludarabine36

Reported measurements

Source class 1
Values in mmol-min/L · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan and Fludarabine6800Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6800
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    units
    Participants
description
Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L.
groups
  1. description
    Intravenous busulfan (Busulfan®) in combination with fludarabine Busulfan: Daily intravenous dosing to target AVC Fludarabine: Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose. Campath: All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times). Stem Cell Transplant: Infusion of bone marrow and donors(related/ unrelated).
    id
    OG000
    title
    Busulfan and Fludarabine
param Type
NUMBER
population Description
The 36 patients refer to the phase I portion of the study only.
reporting Status
POSTED
time Frame
5 years
title
Maximum Tolerated Dose
type
PRIMARY
unit Of Measure
mmol-min/L

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

Preserved source evidence · Not medical advice