TriangleNCT00439465 · OUTCOME
Count of Participants With Increased CD3+CD8+, CD8+ and CD56+ Concentrations Between Day 15 Post-Transplant and Days 21 to 28 Post-transplant
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
- Day 15 post-transplant and between days 21 to 28 post-transplant
What was measured
To demonstrate that the effector cell infusions result in a clinical effect, phenotypic analyses of blood samples using flow cytometry will be performed prior to, and after each infusion, focusing on the CD8 + populations (CD3+CD8+, CD8+CD56+). As a complement to flow cytometry, the following assays will be used to identify cell subset precursor frequencies, subset proliferation, and cytokine production: * Dye Dilution Proliferation Assay (DDPA) 36 - Evaluation of CD8+ T Cell Precursors * ELISPOT-Quantifying cytokine producing T cells:
Analysis population: Sixteen out of nineteen subject samples were analyzed. Three subject's samples were not available for analysis.
Groups in this outcome
Ex-vivo Expanded Effector Cells
Infusing IL-2 and GM-CSF post-HCST Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.
| Group | Source count |
|---|---|
| Ex-vivo Expanded Effector Cells | 16 |
Reported measurements
Day 15
Increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ex-vivo Expanded Effector Cells | 7 | Not reported | Not reported | Not reported | Not reported |
No Increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ex-vivo Expanded Effector Cells | 9 | Not reported | Not reported | Not reported | Not reported |
Days 21-28
Increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ex-vivo Expanded Effector Cells | 7 | Not reported | Not reported | Not reported | Not reported |
No Increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ex-vivo Expanded Effector Cells | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- title
- Increase
- measurements
- group Id
- OG000
- value
- 9
- title
- No Increase
- title
- Day 15
- categories
- measurements
- group Id
- OG000
- value
- 7
- title
- Increase
- measurements
- group Id
- OG000
- value
- 9
- title
- No Increase
- title
- Days 21-28
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- To demonstrate that the effector cell infusions result in a clinical effect, phenotypic analyses of blood samples using flow cytometry will be performed prior to, and after each infusion, focusing on the CD8 + populations (CD3+CD8+, CD8+CD56+). As a complement to flow cytometry, the following assays will be used to identify cell subset precursor frequencies, subset proliferation, and cytokine production: * Dye Dilution Proliferation Assay (DDPA) 36 - Evaluation of CD8+ T Cell Precursors * ELISPOT-Quantifying cytokine producing T cells:
- groups
- description
- Infusing IL-2 and GM-CSF post-HCST Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.
- id
- OG000
- title
- Ex-vivo Expanded Effector Cells
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Sixteen out of nineteen subject samples were analyzed. Three subject's samples were not available for analysis.
- reporting Status
- POSTED
- time Frame
- Day 15 post-transplant and between days 21 to 28 post-transplant
- title
- Count of Participants With Increased CD3+CD8+, CD8+ and CD56+ Concentrations Between Day 15 Post-Transplant and Days 21 to 28 Post-transplant
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice