NCT01119066 · OUTCOME

Survival and Disease-free Survival (DFS)

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: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: at 6 months post transplant

Analysis population: 2 patients received 2 separate transplants on each Arm A and C

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

Group	Source count
Total Body Irradiation, Thiotepa and Cyclophosphamide	125
Busulfan, Melphalan and Fludarabine	213
Clofarabine, Melphalan and Thiotepa	52
Melphalan, Fludarabine and Thiotepa	11

Reported measurements

Survival

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Total Body Irradiation, Thiotepa and Cyclophosphamide	93.3	Not reported	Not reported	Not reported	Not reported
Busulfan, Melphalan and Fludarabine	92.4	Not reported	Not reported	Not reported	Not reported
Clofarabine, Melphalan and Thiotepa	87.2	Not reported	Not reported	Not reported	Not reported
Melphalan, Fludarabine and Thiotepa	90.9	Not reported	Not reported	Not reported	Not reported

Disease Free Survival

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Total Body Irradiation, Thiotepa and Cyclophosphamide	82.5	Not reported	Not reported	Not reported	Not reported
Busulfan, Melphalan and Fludarabine	89.0	Not reported	Not reported	Not reported	Not reported
Clofarabine, Melphalan and Thiotepa	85.1	Not reported	Not reported	Not reported	Not reported
Melphalan, Fludarabine and Thiotepa	90.9	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
93.3
group Id
OG001
value
92.4
group Id
OG002
value
87.2
group Id
OG003
value
90.9
title
Survival
categories
measurements
group Id
OG000
value
82.5
group Id
OG001
value
89.0
group Id
OG002
value
85.1
group Id
OG003
value
90.9
title
Disease Free Survival

denoms

counts
group Id
OG000
value
125
group Id
OG001
value
213
group Id
OG002
value
52
group Id
OG003
value
11
units
Participants

groups

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
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
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
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

NUMBER

population Description

2 patients received 2 separate transplants on each Arm A and C

reporting Status

POSTED

time Frame

at 6 months post transplant

title

Survival and Disease-free Survival (DFS)

type

PRIMARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice