TriangleNCT02408016 · OUTCOME
Number of Participants With Adverse Events
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
- Up to 6 months after the first T cell infusion
What was measured
Based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Analysis population: No patients were treated in Arm II.
Groups in this outcome
Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)
Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)
Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
Arm II (T Lymphocytes, IL-2, Surgery)
Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgical resection
| Group | Source count |
|---|---|
| Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2) | 6 |
| Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2) | 4 |
| Arm II (T Lymphocytes, IL-2, Surgery) | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2) | 6 | Not reported | Not reported | Not reported | Not reported |
| Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2) | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm II (T Lymphocytes, IL-2, Surgery) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
- groups
- description
- Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
- id
- OG000
- title
- Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)
- description
- Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
- id
- OG001
- title
- Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)
- description
- Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgical resection
- id
- OG002
- title
- Arm II (T Lymphocytes, IL-2, Surgery)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- No patients were treated in Arm II.
- reporting Status
- POSTED
- time Frame
- Up to 6 months after the first T cell infusion
- title
- Number of Participants With Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice