NCT01119066 · OUTCOME
Correlation of Doses of CD34+ Progenitors and CD3+ T Cells With Engraftment
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
| Group | Source count |
|---|
| Total Body Irradiation, Thiotepa and Cyclophosphamide | 120 |
|---|
| Busulfan, Melphalan and Fludarabine | 209 |
|---|
| Clofarabine, Melphalan and Thiotepa | 47 |
|---|
| Melphalan, Fludarabine and Thiotepa | 11 |
|---|
Reported measurements
Source class 1
Optimal (> 5x106/kg), Engrafted
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Body Irradiation, Thiotepa and Cyclophosphamide | 103 | Not reported | Not reported | Not reported | Not reported |
|---|
| Busulfan, Melphalan and Fludarabine | 163 | Not reported | Not reported | Not reported | Not reported |
|---|
| Clofarabine, Melphalan and Thiotepa | 38 | Not reported | Not reported | Not reported | Not reported |
|---|
| Melphalan, Fludarabine and Thiotepa | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Optimal (> 5x106/kg), Late Graft Failure
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Body Irradiation, Thiotepa and Cyclophosphamide | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Busulfan, Melphalan and Fludarabine | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Clofarabine, Melphalan and Thiotepa | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Melphalan, Fludarabine and Thiotepa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Optimal (> 5x106/kg), Not Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Body Irradiation, Thiotepa and Cyclophosphamide | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Busulfan, Melphalan and Fludarabine | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Clofarabine, Melphalan and Thiotepa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Melphalan, Fludarabine and Thiotepa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Suboptimal(< 2x106/kg), Engrafted
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Body Irradiation, Thiotepa and Cyclophosphamide | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Busulfan, Melphalan and Fludarabine | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Clofarabine, Melphalan and Thiotepa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Melphalan, Fludarabine and Thiotepa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Suboptimal(< 2x106/kg), Late Graft Failure
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Body Irradiation, Thiotepa and Cyclophosphamide | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Busulfan, Melphalan and Fludarabine | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Clofarabine, Melphalan and Thiotepa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Melphalan, Fludarabine and Thiotepa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Suboptimal(< 2x106/kg), Not Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Body Irradiation, Thiotepa and Cyclophosphamide | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Busulfan, Melphalan and Fludarabine | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Clofarabine, Melphalan and Thiotepa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Melphalan, Fludarabine and Thiotepa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Other(2-5X106/kg), Engrafted
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Body Irradiation, Thiotepa and Cyclophosphamide | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Busulfan, Melphalan and Fludarabine | 40 | Not reported | Not reported | Not reported | Not reported |
|---|
| Clofarabine, Melphalan and Thiotepa | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Melphalan, Fludarabine and Thiotepa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Other(2-5X106/kg), Late Graft Failure
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Body Irradiation, Thiotepa and Cyclophosphamide | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Busulfan, Melphalan and Fludarabine | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Clofarabine, Melphalan and Thiotepa | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Melphalan, Fludarabine and Thiotepa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Other(2-5X106/kg), Not Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Body Irradiation, Thiotepa and Cyclophosphamide | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Busulfan, Melphalan and Fludarabine | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Clofarabine, Melphalan and Thiotepa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Melphalan, Fludarabine and Thiotepa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 103
- group Id
- OG001
- value
- 163
- group Id
- OG002
- value
- 38
- group Id
- OG003
- value
- 11
- title
- Optimal (> 5x106/kg), Engrafted
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- Optimal (> 5x106/kg), Late Graft Failure
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Optimal (> 5x106/kg), Not Evaluable
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Suboptimal(< 2x106/kg), Engrafted
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Suboptimal(< 2x106/kg), Late Graft Failure
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Suboptimal(< 2x106/kg), Not Evaluable
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 0
- title
- Other(2-5X106/kg), Engrafted
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- Other(2-5X106/kg), Late Graft Failure
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Other(2-5X106/kg), Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 120
- group Id
- OG001
- value
- 209
- group Id
- OG002
- value
- 47
- 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
- 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
- Correlation of Doses of CD34+ Progenitors and CD3+ T Cells With Engraftment
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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