TriangleNCT00241358 · OUTCOME
Proportion of Recipients Who Experience Mortality Before Day 100 After Transplant (Recipient Only)
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
- 100 days after transplant
What was measured
-Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause
Analysis population: Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.
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 | 38 |
| Intravenous (IV) Treatment Plan - Donor | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Recipients | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- -Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.
- reporting Status
- POSTED
- time Frame
- 100 days after transplant
- title
- Proportion of Recipients Who Experience Mortality Before Day 100 After Transplant (Recipient Only)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice