TriangleNCT02280811 · OUTCOME
Duration of Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to one year
What was measured
Duration of response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progression is at least a 20% increase in the sum of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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 | 2 |
| 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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | NA | Not reported | NA | NA | Participants had no responses. |
| HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | NA | Not reported | NA | NA | Participants had no responses. |
| HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | NA | Not reported | NA | NA | Participants had no responses. |
| HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 1.5 | Not reported | 0 | 6 | Not reported |
| HPV-16 E6 mTCR PBL MTD + HD IL-2 | NA | Not reported | NA | NA | Participants had no responses. |
Complete source fields
- classes
- categories
- measurements
- comment
- Participants had no responses.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Participants had no responses.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Participants had no responses.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG003
- lower Limit
- 0
- upper Limit
- 6
- value
- 1.5
- comment
- Participants had no responses.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 2
- units
- Participants
- description
- Duration of response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progression is at least a 20% increase in the sum of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- 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
- reporting Status
- POSTED
- time Frame
- up to one year
- title
- Duration of Response
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice