TriangleNCT00241358 · OUTCOME
To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Mean AUC From Time 0 to Infinity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng*hr/mL
- Interval / dispersion
- Full Range
- Time frame
- 0 to 24 hours after dose of IV AMD3100
What was measured
-Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion
Analysis population: Pharmacokinetics were not performed on 2 patients who were considered replacement patients.
Groups in this outcome
Subcutaneous (SC) Treatment Plan - Donor
* Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
Recipients
* Conditioning Regimen * Cyclophosphamide 60mg/kg/day on Days -3 and -2 * TBI 550cGy on Day -1 * GVHD prophylaxis \*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100 * PBSC transplant on Day 0
Intravenous (IV) Treatment Plan - Donor
* Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis * Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
| Group | Source count |
|---|---|
| Subcutaneous (SC) Treatment Plan - Donor | 0 |
| Recipients | 0 |
| Intravenous (IV) Treatment Plan - Donor | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intravenous (IV) Treatment Plan - Donor | 5150 | Not reported | 1243 | 11019 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG002
- lower Limit
- 1243
- upper Limit
- 11019
- value
- 5150
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 19
- units
- Participants
- description
- -Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion
- dispersion Type
- Full Range
- groups
- description
- * Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
- id
- OG000
- title
- Subcutaneous (SC) Treatment Plan - Donor
- description
- * Conditioning Regimen * Cyclophosphamide 60mg/kg/day on Days -3 and -2 * TBI 550cGy on Day -1 * GVHD prophylaxis \*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100 * PBSC transplant on Day 0
- id
- OG001
- title
- Recipients
- description
- * Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis * Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
- id
- OG002
- title
- Intravenous (IV) Treatment Plan - Donor
- param Type
- MEAN
- population Description
- Pharmacokinetics were not performed on 2 patients who were considered replacement patients.
- reporting Status
- POSTED
- time Frame
- 0 to 24 hours after dose of IV AMD3100
- title
- To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Mean AUC From Time 0 to Infinity
- type
- SECONDARY
- unit Of Measure
- ng*hr/mL
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Preserved source evidence · Not medical advice