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NCT00556452 · OUTCOME

One-year Overall Survival Rate for AML

Study of Stem Cell Transplantation for Hematologic Malignancies Using Clofarabine and Busulfan Regimen · Source last updated 2017-12-05

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

Measure
NUMBER
Unit
percent overall survival
Interval / dispersion
95% Confidence Interval
Time frame
1 year

What was measured

Percent Overall Survival (OS) for at one year for subjects with Acute Myeloid Leukemia (AML).

Analysis population: Patients with Acute Myeloid Leukemia (AML)

Groups in this outcome

Clo/BU4

Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment. After pre-conditioning, subjects will receive a peripheral blood stem cell transplant. Total Lymphoid Irradiation : Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant Clofarabine/Busulfan x 4 : Clofarabine IV (dose levels) * 1st dose level: 20 mg/m2/day x 5 days * 2nd dose level: 30 mg/m2/day x 5 days * 3rd dose level: 40 mg/m2/day x 5 days Busulfan IV 3.2 mg/kg daily x 4 days Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment

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

Analysis denominator · Participants

GroupSource count
Clo/BU431

Reported measurements

Source class 1
Values in percent overall survival · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Clo/BU448Not reported3470Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34
        upper Limit
        70
        value
        48
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
Percent Overall Survival (OS) for at one year for subjects with Acute Myeloid Leukemia (AML).
dispersion Type
95% Confidence Interval
groups
  1. description
    Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment. After pre-conditioning, subjects will receive a peripheral blood stem cell transplant. Total Lymphoid Irradiation : Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant Clofarabine/Busulfan x 4 : Clofarabine IV (dose levels) * 1st dose level: 20 mg/m2/day x 5 days * 2nd dose level: 30 mg/m2/day x 5 days * 3rd dose level: 40 mg/m2/day x 5 days Busulfan IV 3.2 mg/kg daily x 4 days Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment
    id
    OG000
    title
    Clo/BU4
param Type
NUMBER
population Description
Patients with Acute Myeloid Leukemia (AML)
reporting Status
POSTED
time Frame
1 year
title
One-year Overall Survival Rate for AML
type
PRIMARY
unit Of Measure
percent overall survival

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

Preserved source evidence · Not medical advice