NCT01245673 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- MAGE-A3, GM-CSF, Hiltonol® (Poly-ICLC), PCV vaccine prior to apheresis. Stem cell mobilization. High-dose melphalan, then hematopoietic stem cells on Day 0. Day 2 Activated/costimulated autologous T cells. Days 14, 42 and 90 MAGE-A3, Hiltonol® and PVC. Day 100 start Lenalidomide. Day 120 and 150 MAGE-A3 and PVC.
- id
- FG000
- title
- MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide,
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 28
- type
- STARTED
- achievements
- comment
- One subject failed to meet screening criteria for the trial.
- group Id
- FG000
- num Subjects
- 27
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Enrollment
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 27
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 27
- comment
- MAGE-A3, GM-CSF, Hiltonol®, PCV vaccine \~10 days before apheresis.
- type
- Pre Transplant Vaccinations 1-3
- achievements
- group Id
- FG000
- num Subjects
- 27
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Pre Transplant Vaccinations
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 27
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 27
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Activated/Costimulated Autologous T Cell
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Off Study due to Disease Progression
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 27
- comment
- On study Days 14, 42 and 90 study participants will receive MAGE-A3, Hiltonol® and PVC vaccine.
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 26
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- MAGE-A3, Hiltonol®, PVC After T Cells
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 26
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 26
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Start Lenalidomide
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 26
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 26
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Maintenance: MAGE-A3, PVC After T Cells
Complete source fields
- groups
- description
- MAGE-A3, GM-CSF, Hiltonol® (Poly-ICLC), PCV vaccine prior to apheresis. Stem cell mobilization. High-dose melphalan, then hematopoietic stem cells on Day 0. Day 2 Activated/costimulated autologous T cells. Days 14, 42 and 90 MAGE-A3, Hiltonol® and PVC. Day 100 start Lenalidomide. Day 120 and 150 MAGE-A3 and PVC.
- id
- FG000
- title
- MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide,
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 28
- type
- STARTED
- achievements
- comment
- One subject failed to meet screening criteria for the trial.
- group Id
- FG000
- num Subjects
- 27
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Enrollment
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 27
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 27
- comment
- MAGE-A3, GM-CSF, Hiltonol®, PCV vaccine \~10 days before apheresis.
- type
- Pre Transplant Vaccinations 1-3
- achievements
- group Id
- FG000
- num Subjects
- 27
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Pre Transplant Vaccinations
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 27
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 27
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Activated/Costimulated Autologous T Cell
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Off Study due to Disease Progression
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 27
- comment
- On study Days 14, 42 and 90 study participants will receive MAGE-A3, Hiltonol® and PVC vaccine.
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 26
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- MAGE-A3, Hiltonol®, PVC After T Cells
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 26
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 26
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Start Lenalidomide
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 26
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 26
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Maintenance: MAGE-A3, PVC After T Cells
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