NCT03132922 · OUTCOME
Best Overall Response (BOR)
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
- From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)
What was measured
BOR was defined as the best response recorded from the date of T-cell infusion until disease progression. Response categories from best to worst were, confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), and not evaluable (NE) (per RECIST v1.1)
Analysis population: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel
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
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
| Group | Source count |
|---|---|
| Afamitresgene Autoleucel, Group 1 | 3 |
| Afamitresgene Autoleucel, Group 2 | 3 |
| Afamitresgene Autoleucel, Group 3 + Expansion | 32 |
| Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | 4 |
Reported measurements
Complete response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afamitresgene Autoleucel, Group 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Afamitresgene Autoleucel, Group 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Afamitresgene Autoleucel, Group 3 + Expansion | 0 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | 0 | Not reported | Not reported | Not reported | Not reported |
Partial response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afamitresgene Autoleucel, Group 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Afamitresgene Autoleucel, Group 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Afamitresgene Autoleucel, Group 3 + Expansion | 9 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | 1 | Not reported | Not reported | Not reported | Not reported |
Stable disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afamitresgene Autoleucel, Group 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Afamitresgene Autoleucel, Group 2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Afamitresgene Autoleucel, Group 3 + Expansion | 14 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | 3 | Not reported | Not reported | Not reported | Not reported |
Progressive disease (PD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afamitresgene Autoleucel, Group 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Afamitresgene Autoleucel, Group 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Afamitresgene Autoleucel, Group 3 + Expansion | 6 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | 0 | Not reported | Not reported | Not reported | Not reported |
Not evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afamitresgene Autoleucel, Group 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Afamitresgene Autoleucel, Group 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Afamitresgene Autoleucel, Group 3 + Expansion | 3 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Complete response
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 1
- title
- Partial response
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 3
- title
- Stable disease
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 0
- title
- Progressive disease (PD)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- title
- Not evaluable
- 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
- BOR was defined as the best response recorded from the date of T-cell infusion until disease progression. Response categories from best to worst were, confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), and not evaluable (NE) (per RECIST v1.1)
- 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.
- id
- OG003
- title
- Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel
- reporting Status
- POSTED
- time Frame
- From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)
- title
- Best Overall Response (BOR)
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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