Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01119066 · OUTCOME

The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.

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

Engrafted
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Total Body Irradiation, Thiotepa and Cyclophosphamide118Not reportedNot reportedNot reportedNot reported
Busulfan, Melphalan and Fludarabine205Not reportedNot reportedNot reportedNot reported
Clofarabine, Melphalan and Thiotepa45Not reportedNot reportedNot reportedNot reported
Melphalan, Fludarabine and Thiotepa10Not reportedNot reportedNot reportedNot reported
Primary Graft Failure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Total Body Irradiation, Thiotepa and Cyclophosphamide0Not reportedNot reportedNot reportedNot reported
Busulfan, Melphalan and Fludarabine0Not reportedNot reportedNot reportedNot reported
Clofarabine, Melphalan and Thiotepa0Not reportedNot reportedNot reportedNot reported
Melphalan, Fludarabine and Thiotepa0Not reportedNot reportedNot reportedNot reported
Late graft failure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Total Body Irradiation, Thiotepa and Cyclophosphamide1Not reportedNot reportedNot reportedNot reported
Busulfan, Melphalan and Fludarabine5Not reportedNot reportedNot reportedNot reported
Clofarabine, Melphalan and Thiotepa2Not reportedNot reportedNot reportedNot reported
Melphalan, Fludarabine and Thiotepa1Not reportedNot reportedNot reportedNot reported
Not Evaluable Engraftment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Total Body Irradiation, Thiotepa and Cyclophosphamide1Not reportedNot reportedNot reportedNot reported
Busulfan, Melphalan and Fludarabine0Not reportedNot reportedNot reportedNot reported
Clofarabine, Melphalan and Thiotepa0Not reportedNot reportedNot reportedNot reported
Melphalan, Fludarabine and Thiotepa0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        118
      2. group Id
        OG001
        value
        205
      3. group Id
        OG002
        value
        45
      4. group Id
        OG003
        value
        10
    title
    Engrafted
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Primary Graft Failure
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        1
    title
    Late graft failure
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Not Evaluable Engraftment
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
The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice