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NCT00054327 · OUTCOME

Rates of Durable Engraftment

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer · Source last updated 2013-07-24

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

Measure
MEAN
Unit
days
Interval / dispersion
Standard Deviation
Time frame
at day 42

What was measured

Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC \>500/µl and platelets \>20K/µl without transfusion support.

Groups in this outcome

Regimen A

Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.

Regimen B-1

Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..

Regimen B-2

Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.

Regimen B-3

Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.

Regimen C

Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.

Regimen D

Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.

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

Analysis denominator · Participants

GroupSource count
Regimen A10
Regimen B-14
Regimen B-23
Regimen B-34
Regimen C10
Regimen D2

Reported measurements

Source class 1
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Regimen A17.95.801341Not reportedNot reportedNot reported
Regimen B-115.756.946222Not reportedNot reportedNot reported
Regimen B-2133Not reportedNot reportedNot reported
Regimen B-318.254.573474Not reportedNot reportedNot reported
Regimen C13.95.237684Not reportedNot reportedNot reported
Regimen D10.50.707107Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.801341
        value
        17.9
      2. group Id
        OG001
        spread
        6.946222
        value
        15.75
      3. group Id
        OG002
        spread
        3
        value
        13
      4. group Id
        OG003
        spread
        4.573474
        value
        18.25
      5. group Id
        OG004
        spread
        5.237684
        value
        13.9
      6. group Id
        OG005
        spread
        0.707107
        value
        10.5
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      2
    units
    Participants
description
Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC \>500/µl and platelets \>20K/µl without transfusion support.
dispersion Type
Standard Deviation
groups
  1. description
    Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
    id
    OG000
    title
    Regimen A
  2. description
    Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
    id
    OG001
    title
    Regimen B-1
  3. description
    Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
    id
    OG002
    title
    Regimen B-2
  4. description
    Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
    id
    OG003
    title
    Regimen B-3
  5. description
    Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
    id
    OG004
    title
    Regimen C
  6. description
    Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
    id
    OG005
    title
    Regimen D
param Type
MEAN
reporting Status
POSTED
time Frame
at day 42
title
Rates of Durable Engraftment
type
PRIMARY
unit Of Measure
days

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Preserved source evidence · Not medical advice