NCT03132922 · OUTCOME
Replication Competent Lentivirus (RCL)
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 to 3 months post-infusion
What was measured
The presence of RCL was assessed by quantitative polymerase chain reaction (qPCR) targeting a segment of the vesicular stomatitis virus glycoprotein (VSV-G) coding sequence.
Analysis population: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel and had a post-infusion sample tested for VSV-G by qPCR (RCL)
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
Source class 1
| 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 |
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
- 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
- The presence of RCL was assessed by quantitative polymerase chain reaction (qPCR) targeting a segment of the vesicular stomatitis virus glycoprotein (VSV-G) coding sequence.
- 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 and had a post-infusion sample tested for VSV-G by qPCR (RCL)
- reporting Status
- POSTED
- time Frame
- From afamitresgene autoleucel infusion to 3 months post-infusion
- title
- Replication Competent Lentivirus (RCL)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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