NCT03132922 · OUTCOME
Peak Persistence
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- DNA copies/microgram
- Interval / dispersion
- Standard Deviation
- Time frame
- From afamitresgene autoleucel infusion up to 18 months post-infusion
What was measured
Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).
Analysis population: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel and had a post-infusion sample tested for persistence
Groups in this outcome
Afamitresgene Autoleucel, Group 1
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
Afamitresgene Autoleucel, Group 2
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
Afamitresgene Autoleucel Group 3 + Expansion
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion (1.2-10x10\^9 transduced cells).
| Group | Source count |
|---|---|
| Afamitresgene Autoleucel, Group 1 | 3 |
| Afamitresgene Autoleucel, Group 2 | 3 |
| Afamitresgene Autoleucel Group 3 + Expansion | 32 |
| Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afamitresgene Autoleucel, Group 1 | 10766.23 | 12504.705 | Not reported | Not reported | Not reported |
| Afamitresgene Autoleucel, Group 2 | 88900.26 | 53873.432 | Not reported | Not reported | Not reported |
| Afamitresgene Autoleucel Group 3 + Expansion | 165035.89 | 99806.129 | Not reported | Not reported | Not reported |
| Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | 185,532.5800 | 116322.7494 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12504.705
- value
- 10766.23
- group Id
- OG001
- spread
- 53873.432
- value
- 88900.26
- group Id
- OG002
- spread
- 99806.129
- value
- 165035.89
- group Id
- OG003
- spread
- 116322.7494
- value
- 185,532.5800
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 32
- group Id
- OG003
- value
- 4
- units
- Participants
- description
- Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).
- dispersion Type
- Standard Deviation
- groups
- description
- Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
- id
- OG000
- title
- Afamitresgene Autoleucel, Group 1
- description
- Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
- id
- OG001
- title
- Afamitresgene Autoleucel, Group 2
- description
- Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
- id
- OG002
- title
- Afamitresgene Autoleucel Group 3 + Expansion
- description
- Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion (1.2-10x10\^9 transduced cells).
- id
- OG003
- title
- Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
- param Type
- MEAN
- population Description
- Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel and had a post-infusion sample tested for persistence
- reporting Status
- POSTED
- time Frame
- From afamitresgene autoleucel infusion up to 18 months post-infusion
- title
- Peak Persistence
- type
- PRIMARY
- unit Of Measure
- DNA copies/microgram
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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