NCT01875237 · OUTCOME
To Assess the Proportions of GvHD Response Post-administration of AP1903.
Donor Lymphocyte Infusion (DLI) of T-cells Genetically Modified With iCasp9 Suicide Gene · Source last updated 2019-07-16
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 3, 7, 14, 28, and 56 post-administration of AP1903
What was measured
To assess the proportions of GvHD complete response (CR), partial response (PR), mixed response, no response, and progression among surviving patients at Day 3, 7, 14, 28, and 56 post-administration of AP1903.
Analysis population: Patient who received DLI
Groups in this outcome
Transplant Only
Patients who did not move forward to DLI
Transplat Plus DLI
Proceeded to DLI per protocol
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Transplant Only | 0 |
|---|
| Transplat Plus DLI | 1 |
|---|
Reported measurements
Day 3 post-administration of AP1903
complete response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
partial response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
no response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
progression
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 7 post-administration of AP1903
complete response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
partial response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
no response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
progression
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 14 post-administration of AP1903
complete response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
partial response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
no response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
progression
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 28 post-administration of AP1903
complete response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
partial response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
no response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
progression
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 56 post-administration of AP1903
complete response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
partial response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
no response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
progression
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Transplant Only | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Transplat Plus DLI | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- complete response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- partial response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- no response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- progression
- title
- Day 3 post-administration of AP1903
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- complete response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- partial response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- no response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- progression
- title
- Day 7 post-administration of AP1903
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- complete response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- partial response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- no response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- progression
- title
- Day 14 post-administration of AP1903
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- complete response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- partial response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- no response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- progression
- title
- Day 28 post-administration of AP1903
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- complete response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- partial response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- no response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- progression
- title
- Day 56 post-administration of AP1903
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- To assess the proportions of GvHD complete response (CR), partial response (PR), mixed response, no response, and progression among surviving patients at Day 3, 7, 14, 28, and 56 post-administration of AP1903.
- groups
- description
- Patients who did not move forward to DLI
- id
- OG000
- title
- Transplant Only
- description
- Proceeded to DLI per protocol
- id
- OG001
- title
- Transplat Plus DLI
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Patient who received DLI
- reporting Status
- POSTED
- time Frame
- Day 3, 7, 14, 28, and 56 post-administration of AP1903
- title
- To Assess the Proportions of GvHD Response Post-administration of AP1903.
- type
- SECONDARY
- unit Of Measure
- Participants
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