TriangleNCT01640301 · OUTCOME
Anti-leukemic Potential Efficacy, in Terms of Duration of Response (Arm II)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Full Range
- Time frame
- Up to 1 year
What was measured
Response is assessed throughout the 1 year post treatment timeframe. Morphologic criteria for response: Complete Response (CR) = Bone Marrow blasts \<5%; no blasts with Auer rods; no extramedullary disease. Transfusion independent. Platelets ≥ 100,000/μl Absolute neutrophil count \>1000/μl (CRi: incomplete hematologic recovery CRp: incomplete platelet recovery) Partial Response (PR) = Decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow and the normalization of blood counts as for CR. (PRi and PRp if incomplete hematologic or platelet recovery) Stable Disease (SD) = Failure to achieve at least PR, but no evidence of progression for \>4 weeks.
Analysis population: 4 patients in Arm II did not relapse and were not assessed. 1 pt progressed at their D365 visit timepoint which landed on D367. They were included in the count of participants that passed within their 1 year follow-up timeframe.
Groups in this outcome
Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)
Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.
| Group | Source count |
|---|---|
| Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) | 28 | Not reported | 5 | 367 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5
- upper Limit
- 367
- value
- 28
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- description
- Response is assessed throughout the 1 year post treatment timeframe. Morphologic criteria for response: Complete Response (CR) = Bone Marrow blasts \<5%; no blasts with Auer rods; no extramedullary disease. Transfusion independent. Platelets ≥ 100,000/μl Absolute neutrophil count \>1000/μl (CRi: incomplete hematologic recovery CRp: incomplete platelet recovery) Partial Response (PR) = Decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow and the normalization of blood counts as for CR. (PRi and PRp if incomplete hematologic or platelet recovery) Stable Disease (SD) = Failure to achieve at least PR, but no evidence of progression for \>4 weeks.
- dispersion Type
- Full Range
- groups
- description
- Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.
- id
- OG000
- title
- Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)
- param Type
- MEDIAN
- population Description
- 4 patients in Arm II did not relapse and were not assessed. 1 pt progressed at their D365 visit timepoint which landed on D367. They were included in the count of participants that passed within their 1 year follow-up timeframe.
- reporting Status
- POSTED
- time Frame
- Up to 1 year
- title
- Anti-leukemic Potential Efficacy, in Terms of Duration of Response (Arm II)
- type
- PRIMARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice