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NCT00856388 · OUTCOME

3 yr Overall Survival

Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders · Source last updated 2019-11-13

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 4.5 years

What was measured

3 yr Overall Survival estimated using the Kaplan-Meier method.

Analysis population: All treated and eligible patients

Groups in this outcome

Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)

Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo total-body irradiation allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation anti-thymocyte globulin: Given IV

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

Analysis denominator · Participants

GroupSource count
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)61

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)46.0Not reported33.057.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.0
        upper Limit
        57.0
        value
        46.0
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    units
    Participants
description
3 yr Overall Survival estimated using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo total-body irradiation allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation anti-thymocyte globulin: Given IV
    id
    OG000
    title
    Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
param Type
NUMBER
population Description
All treated and eligible patients
reporting Status
POSTED
time Frame
Up to 4.5 years
title
3 yr Overall Survival
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice