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NCT00608517 · OUTCOME

Number of Participants With 100-day Non-relapse Mortality

Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil · Source last updated 2014-05-20

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
100 days

What was measured

Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF).

Groups in this outcome

Pediatric Myeloablative Conditioning

Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.

Adult Myeloablative Conditioning

Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.

Reduced-intensity Conditioning

Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.

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

Analysis denominator · Participants

GroupSource count
Pediatric Myeloablative Conditioning2
Adult Myeloablative Conditioning3
Reduced-intensity Conditioning1

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pediatric Myeloablative Conditioning1Not reportedNot reportedNot reportedNot reported
Adult Myeloablative Conditioning0Not reportedNot reportedNot reportedNot reported
Reduced-intensity Conditioning0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF).
groups
  1. description
    Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
    id
    OG000
    title
    Pediatric Myeloablative Conditioning
  2. description
    Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
    id
    OG001
    title
    Adult Myeloablative Conditioning
  3. description
    Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
    id
    OG002
    title
    Reduced-intensity Conditioning
param Type
NUMBER
reporting Status
POSTED
time Frame
100 days
title
Number of Participants With 100-day Non-relapse Mortality
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice