TriangleNCT02280811 · OUTCOME
Percentage of Cluster of Differentiation 3 (CD3+) Cells That Are E6 T-Cell Receptor Memory of Circulating T-Cells in Responders and Non-responders
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percentage of cells
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- One month after treatment
What was measured
Detection of E6 TCR T cells in patients peripheral blood leukocytes (PBL)/apheresis samples by flow cytometry.
Analysis population: One patient in group HPV-16 E6 mTCR PBL 1x10\^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point.
Groups in this outcome
HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
HPV-16 E6 mTCR PBL MTD + HD IL-2
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
| Group | Source count |
|---|---|
| HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 1 |
| HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 1 |
| HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 1 |
| HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 6 |
| HPV-16 E6 mTCR PBL MTD + HD IL-2 | 2 |
Reported measurements
Responders
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | NA | Not reported | Not reported | Not reported | There were no responders in this group so that means they did not have a mean percentage of E6 TCR cells at one month. |
| HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | NA | Not reported | Not reported | Not reported | There were no responders in this group so that means they did not have a mean percentage of E6 TCR cells at one month. |
| HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | NA | Not reported | Not reported | Not reported | There were no responders in this group so that means they did not have a mean percentage of E6 TCR cells at one month. |
| HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 38 | Not reported | 30.1 | 45.9 | Not reported |
| HPV-16 E6 mTCR PBL MTD + HD IL-2 | NA | Not reported | NA | NA | There were no responders in this group so that means they did not have a mean percentage of E6 TCR cells at one month. |
Non-responders
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 30.7 | Not reported | 30.7 | 30.7 | Not reported |
| HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 4.4 | Not reported | 4.4 | 4.4 | Not reported |
| HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 12.6 | Not reported | 12.6 | 12.6 | Not reported |
| HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 29.9 | Not reported | 10.4 | 44.4 | Not reported |
| HPV-16 E6 mTCR PBL MTD + HD IL-2 | 37.1 | Not reported | 21.7 | 52.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- There were no responders in this group so that means they did not have a mean percentage of E6 TCR cells at one month.
- group Id
- OG000
- value
- NA
- comment
- There were no responders in this group so that means they did not have a mean percentage of E6 TCR cells at one month.
- group Id
- OG001
- value
- NA
- comment
- There were no responders in this group so that means they did not have a mean percentage of E6 TCR cells at one month.
- group Id
- OG002
- value
- NA
- group Id
- OG003
- lower Limit
- 30.1
- upper Limit
- 45.9
- value
- 38
- comment
- There were no responders in this group so that means they did not have a mean percentage of E6 TCR cells at one month.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Responders
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30.7
- upper Limit
- 30.7
- value
- 30.7
- group Id
- OG001
- lower Limit
- 4.4
- upper Limit
- 4.4
- value
- 4.4
- group Id
- OG002
- lower Limit
- 12.6
- upper Limit
- 12.6
- value
- 12.6
- group Id
- OG003
- lower Limit
- 10.4
- upper Limit
- 44.4
- value
- 29.9
- group Id
- OG004
- lower Limit
- 21.7
- upper Limit
- 52.5
- value
- 37.1
- title
- Non-responders
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 2
- units
- Participants
- description
- Detection of E6 TCR T cells in patients peripheral blood leukocytes (PBL)/apheresis samples by flow cytometry.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
- id
- OG000
- title
- HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2
- description
- patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
- id
- OG001
- title
- HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2
- description
- patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
- id
- OG002
- title
- HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2
- description
- patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
- id
- OG003
- title
- HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2
- description
- patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
- id
- OG004
- title
- HPV-16 E6 mTCR PBL MTD + HD IL-2
- param Type
- MEAN
- population Description
- One patient in group HPV-16 E6 mTCR PBL 1x10\^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point.
- reporting Status
- POSTED
- time Frame
- One month after treatment
- title
- Percentage of Cluster of Differentiation 3 (CD3+) Cells That Are E6 T-Cell Receptor Memory of Circulating T-Cells in Responders and Non-responders
- type
- SECONDARY
- unit Of Measure
- percentage of cells
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Preserved source evidence · Not medical advice