TriangleNCT00241358 · OUTCOME
To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Cmax
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/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 | 1058 | Not reported | 214 | 2150 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG002
- lower Limit
- 214
- upper Limit
- 2150
- value
- 1058
- 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 Cmax
- type
- SECONDARY
- unit Of Measure
- ng/ml
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Preserved source evidence · Not medical advice