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NCT01119066 · OUTCOME

Incidence of Non-relapse Mortality (Transplant-related Mortality) Following Each Cytoreduction Regimen and a Transplant Fractionated by the CliniMACS System.

HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies · Source last updated 2022-08-05

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
3 years

Analysis population: Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.

Groups in this outcome

Total Body Irradiation, Thiotepa and Cyclophosphamide

Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated) total body irradiation: dose of 1375-1500 cGy Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Cyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated). (CliniMACS) T-cell depleted PBSC Transplant

Busulfan, Melphalan and Fludarabine

Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5) Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics Melphalan: 70mg/m2/day x 2 Fludarabine: 25mg/m2/ day x 5 (CliniMACS) T-cell depleted PBSC Transplant

Clofarabine, Melphalan and Thiotepa

Clofarabine (20mg/m2/ day x 5) (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1) Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Melphalan: 70mg/m2/day x 2 Clofarabine: 20mg/m2/ day x 5 (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval) (CliniMACS) T-cell depleted PBSC Transplant

Melphalan, Fludarabine and Thiotepa

Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1) Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Melphalan: 70mg/m2/day x 2 (CliniMACS) T-cell depleted PBSC Transplant

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

Analysis denominator · Participants

GroupSource count
Total Body Irradiation, Thiotepa and Cyclophosphamide120
Busulfan, Melphalan and Fludarabine210
Clofarabine, Melphalan and Thiotepa47
Melphalan, Fludarabine and Thiotepa11

Reported measurements

Alive
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Total Body Irradiation, Thiotepa and Cyclophosphamide81Not reportedNot reportedNot reportedNot reported
Busulfan, Melphalan and Fludarabine145Not reportedNot reportedNot reportedNot reported
Clofarabine, Melphalan and Thiotepa30Not reportedNot reportedNot reportedNot reported
Melphalan, Fludarabine and Thiotepa8Not reportedNot reportedNot reportedNot reported
Dead (not non-relapse mortality)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Total Body Irradiation, Thiotepa and Cyclophosphamide23Not reportedNot reportedNot reportedNot reported
Busulfan, Melphalan and Fludarabine24Not reportedNot reportedNot reportedNot reported
Clofarabine, Melphalan and Thiotepa3Not reportedNot reportedNot reportedNot reported
Melphalan, Fludarabine and Thiotepa0Not reportedNot reportedNot reportedNot reported
Dead (non-relapse mortality)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Total Body Irradiation, Thiotepa and Cyclophosphamide16Not reportedNot reportedNot reportedNot reported
Busulfan, Melphalan and Fludarabine41Not reportedNot reportedNot reportedNot reported
Clofarabine, Melphalan and Thiotepa14Not reportedNot reportedNot reportedNot reported
Melphalan, Fludarabine and Thiotepa3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        81
      2. group Id
        OG001
        value
        145
      3. group Id
        OG002
        value
        30
      4. group Id
        OG003
        value
        8
    title
    Alive
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        0
    title
    Dead (not non-relapse mortality)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        41
      3. group Id
        OG002
        value
        14
      4. group Id
        OG003
        value
        3
    title
    Dead (non-relapse mortality)
denoms
  1. counts
    1. group Id
      OG000
      value
      120
    2. group Id
      OG001
      value
      210
    3. group Id
      OG002
      value
      47
    4. group Id
      OG003
      value
      11
    units
    Participants
groups
  1. description
    Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated) total body irradiation: dose of 1375-1500 cGy Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Cyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated). (CliniMACS) T-cell depleted PBSC Transplant
    id
    OG000
    title
    Total Body Irradiation, Thiotepa and Cyclophosphamide
  2. description
    Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5) Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics Melphalan: 70mg/m2/day x 2 Fludarabine: 25mg/m2/ day x 5 (CliniMACS) T-cell depleted PBSC Transplant
    id
    OG001
    title
    Busulfan, Melphalan and Fludarabine
  3. description
    Clofarabine (20mg/m2/ day x 5) (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1) Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Melphalan: 70mg/m2/day x 2 Clofarabine: 20mg/m2/ day x 5 (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval) (CliniMACS) T-cell depleted PBSC Transplant
    id
    OG002
    title
    Clofarabine, Melphalan and Thiotepa
  4. description
    Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1) Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Melphalan: 70mg/m2/day x 2 (CliniMACS) T-cell depleted PBSC Transplant
    id
    OG003
    title
    Melphalan, Fludarabine and Thiotepa
param Type
COUNT_OF_PARTICIPANTS
population Description
Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.
reporting Status
POSTED
time Frame
3 years
title
Incidence of Non-relapse Mortality (Transplant-related Mortality) Following Each Cytoreduction Regimen and a Transplant Fractionated by the CliniMACS System.
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice