TriangleNCT02259348 · OUTCOME
Event-free Survival (EFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- one year post transplantation
What was measured
The Kaplan-Meier estimate of event-free survival (EFS) along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\\kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.
Groups in this outcome
Participants
Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
| Group | Source count |
|---|---|
| Participants | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Participants | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- The Kaplan-Meier estimate of event-free survival (EFS) along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\\kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.
- groups
- description
- Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
- id
- OG000
- title
- Participants
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- one year post transplantation
- title
- Event-free Survival (EFS)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice