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NCT00003816 · OUTCOME

4 Year PFS

Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer · Source last updated 2021-08-13

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
4 years

What was measured

progression free survival estimate at 4 years post BMT (events are disease progression/relapse and death due to any cause)

Groups in this outcome

BuCy

Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. busulfan: Given IV cyclophosphamide: Given IV

CyTBI

Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1. cyclophosphamide: Given IV total-body irradiation: Given twice daily for 3 days

FluMel

Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2. fludarabine phosphate: Given IV melphalan: Given IV

VpCyTBI

Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1. cyclophosphamide: Given IV etoposide: Given IV total-body irradiation: Given twice daily for 3 days

Other

Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1. OR Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3. OR Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. OR Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2. OR Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.

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

Analysis denominator · Participants

GroupSource count
BuCy55
CyTBI69
FluMel199
VpCyTBI23
Other15

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
BuCy49.1Not reported3662.2Not reported
CyTBI52.2Not reported40.464Not reported
FluMel33.2Not reported26.739.7Not reported
VpCyTBI26.1Not reported8.144.1Not reported
Other40Not reported15.364.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        36
        upper Limit
        62.2
        value
        49.1
      2. group Id
        OG001
        lower Limit
        40.4
        upper Limit
        64
        value
        52.2
      3. group Id
        OG002
        lower Limit
        26.7
        upper Limit
        39.7
        value
        33.2
      4. group Id
        OG003
        lower Limit
        8.1
        upper Limit
        44.1
        value
        26.1
      5. group Id
        OG004
        lower Limit
        15.3
        upper Limit
        64.7
        value
        40
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    2. group Id
      OG001
      value
      69
    3. group Id
      OG002
      value
      199
    4. group Id
      OG003
      value
      23
    5. group Id
      OG004
      value
      15
    units
    Participants
description
progression free survival estimate at 4 years post BMT (events are disease progression/relapse and death due to any cause)
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. busulfan: Given IV cyclophosphamide: Given IV
    id
    OG000
    title
    BuCy
  2. description
    Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1. cyclophosphamide: Given IV total-body irradiation: Given twice daily for 3 days
    id
    OG001
    title
    CyTBI
  3. description
    Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2. fludarabine phosphate: Given IV melphalan: Given IV
    id
    OG002
    title
    FluMel
  4. description
    Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1. cyclophosphamide: Given IV etoposide: Given IV total-body irradiation: Given twice daily for 3 days
    id
    OG003
    title
    VpCyTBI
  5. description
    Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1. OR Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3. OR Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. OR Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2. OR Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
    id
    OG004
    title
    Other
param Type
NUMBER
reporting Status
POSTED
time Frame
4 years
title
4 Year PFS
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice