TriangleNCT02280811 · OUTCOME
Number of Participants With a Dose Limiting Toxicity (DLT)
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
- 19 months and 7 days
What was measured
A dose limiting toxicity is all Grade 3 and greater toxicities with the exception of myelosuppression, defined as lymphopenia, neutropenia, decreased hemoglobin, and thrombocytopenia, due to chemotherapy preparative regimen. Aldesleukin expected toxicities as defined in Appendix 2 and 3 of the protocol. Expected chemotherapy toxicities as defined in the pharmaceutical information section. Immediate hypersensitivity reactions (excluding symptomatic bronchospasm and grade 4 hypotension) occurring within 2 hours of cell infusion (related to cell infusion) that are reversible to a grade 2 or less within 24 hours of cell administration with standard therapy. Grade 3 fever. Events that are clearly related to the patient's disease.
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 | 0 | Not reported | Not reported | Not reported | Not reported |
| HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 0 | Not reported | Not reported | Not reported | Not reported |
| HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 0 | Not reported | Not reported | Not reported | Not reported |
| HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 0 | Not reported | Not reported | Not reported | Not reported |
| HPV-16 E6 mTCR PBL MTD + HD IL-2 | 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
- group Id
- OG004
- value
- 0
- 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
- A dose limiting toxicity is all Grade 3 and greater toxicities with the exception of myelosuppression, defined as lymphopenia, neutropenia, decreased hemoglobin, and thrombocytopenia, due to chemotherapy preparative regimen. Aldesleukin expected toxicities as defined in Appendix 2 and 3 of the protocol. Expected chemotherapy toxicities as defined in the pharmaceutical information section. Immediate hypersensitivity reactions (excluding symptomatic bronchospasm and grade 4 hypotension) occurring within 2 hours of cell infusion (related to cell infusion) that are reversible to a grade 2 or less within 24 hours of cell administration with standard therapy. Grade 3 fever. Events that are clearly related to the patient's disease.
- 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
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 19 months and 7 days
- title
- Number of Participants With a Dose Limiting Toxicity (DLT)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice