TriangleNCT01239368 · OUTCOME
Number of Participants With Progression Free Survival in Cohort A Th1 (Type 1 T Helper Cells)/Tc1 (T Cytotoxic Cells, Type 1) Rapa Prevention of Relapse
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
- Study completion at 22 months
What was measured
Progressive disease is assessed by the Consensus of the International Myeloma Working Group criteria and is defined as one or more of the following: Increases of greater or equal to 25% in serum M-component (minimum absolute increase of 0.5 g/dl) or urine M-component (minimum absolute increase of 200mg/24h) or percentage of bone marrow plasma cells (minimum absolute percentage of 10%) or size of bone lesions or new plasmacytoma, or development of hypercalcemia solely attributable to the disease.
Analysis population: The PFS was only used in cohort A, which had just one patient.
Groups in this outcome
Cohort A - Th1/Tc1.Rapa Prevention of Relapse
Th1/Tc1.Rapa Prevention of Relapse Adoptive Immunotherapy: Th1 (type 1 T helper cells)/Tc1 (T cytotoxic cells, type 1) Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Rapamycin-Generated Autologous Th1/Tc1.Rapa Cells: Six Th1.rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight. Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg
| Group | Source count |
|---|---|
| Cohort A - Th1/Tc1.Rapa Prevention of Relapse | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A - Th1/Tc1.Rapa Prevention of Relapse | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 1
- units
- Participants
- description
- Progressive disease is assessed by the Consensus of the International Myeloma Working Group criteria and is defined as one or more of the following: Increases of greater or equal to 25% in serum M-component (minimum absolute increase of 0.5 g/dl) or urine M-component (minimum absolute increase of 200mg/24h) or percentage of bone marrow plasma cells (minimum absolute percentage of 10%) or size of bone lesions or new plasmacytoma, or development of hypercalcemia solely attributable to the disease.
- groups
- description
- Th1/Tc1.Rapa Prevention of Relapse Adoptive Immunotherapy: Th1 (type 1 T helper cells)/Tc1 (T cytotoxic cells, type 1) Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Rapamycin-Generated Autologous Th1/Tc1.Rapa Cells: Six Th1.rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight. Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg
- id
- OG000
- title
- Cohort A - Th1/Tc1.Rapa Prevention of Relapse
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The PFS was only used in cohort A, which had just one patient.
- reporting Status
- POSTED
- time Frame
- Study completion at 22 months
- title
- Number of Participants With Progression Free Survival in Cohort A Th1 (Type 1 T Helper Cells)/Tc1 (T Cytotoxic Cells, Type 1) Rapa Prevention of Relapse
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice