NCT01119066 · FLOW

Participant flow

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.

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
FG000
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
FG001
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
FG002
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
FG003
title
Melphalan, Fludarabine and Thiotepa

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
4
group Id
FG001
num Subjects
6
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
0
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
1
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
0
type
Concern regarding adequacy of transplant cell dose
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
0
type
Relapse identified before transplant
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
3
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
0
type
Intercurrent medication condition rendered patient ineligible
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
4
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
0
type
Relapse identified before transplant
milestones
achievements
group Id
FG000
num Subjects
132
num Units
1
group Id
FG001
num Subjects
227
num Units
0
group Id
FG002
num Subjects
52
num Units
1
group Id
FG003
num Subjects
11
num Units
0
type
STARTED
achievements
group Id
FG000
num Subjects
125
num Units
1
group Id
FG001
num Subjects
213
num Units
0
group Id
FG002
num Subjects
52
num Units
1
group Id
FG003
num Subjects
11
num Units
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
7
num Units
0
group Id
FG001
num Subjects
14
num Units
0
group Id
FG002
num Subjects
0
num Units
0
group Id
FG003
num Subjects
0
num Units
0
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

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

type Units Analyzed

Additional Transplant

Complete source fields