NCT01318317 · OUTCOME
Number of Days of Quantifiable CD19 CAR Post T-cell Infusion
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- days
- Interval / dispersion
- Standard Deviation
- Time frame
- 28 days post T cell infusion
What was measured
WPRE persistence of quantifiable CD19 CAR summarized with mean and standard deviation
Analysis population: 1 participant in dose level 1 did not have any whole blood samples to analyze. Overall mean was reported due to small samples sizes in each dose level.
Groups in this outcome
Treatment (Cellular Adoptive Immunotherapy Following PBSCT)
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation. peripheral blood stem cell transplantation (PBSCT): Undergo autologous PBSCT filgrastim: Given IV polymerase chain reaction: Correlative studies rituximab: Given IV genetically engineered lymphocyte therapy: Receive ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) laboratory biomarker analysis: Correlative studies plerixafor: Given IV autologous hematopoietic stem cell transplantation: Undergo autologous PBSCT
| Group | Source count |
|---|---|
| Treatment (Cellular Adoptive Immunotherapy Following PBSCT) | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Cellular Adoptive Immunotherapy Following PBSCT) | 18.25 | 12.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.1
- value
- 18.25
- denoms
- counts
- group Id
- OG000
- value
- 7
- units
- Participants
- description
- WPRE persistence of quantifiable CD19 CAR summarized with mean and standard deviation
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with Granulocyte-Colony Stimulating Factor (G-CSF) and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplantation. Patients receive standard myeloablative conditioning followed by autologous Peripheral Blood Stem Cell Transplant (PBSCT). Patients then undergo infusion of ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) on day 2 or 3 after transplantation. peripheral blood stem cell transplantation (PBSCT): Undergo autologous PBSCT filgrastim: Given IV polymerase chain reaction: Correlative studies rituximab: Given IV genetically engineered lymphocyte therapy: Receive ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR) laboratory biomarker analysis: Correlative studies plerixafor: Given IV autologous hematopoietic stem cell transplantation: Undergo autologous PBSCT
- id
- OG000
- title
- Treatment (Cellular Adoptive Immunotherapy Following PBSCT)
- param Type
- MEAN
- population Description
- 1 participant in dose level 1 did not have any whole blood samples to analyze. Overall mean was reported due to small samples sizes in each dose level.
- reporting Status
- POSTED
- time Frame
- 28 days post T cell infusion
- title
- Number of Days of Quantifiable CD19 CAR Post T-cell Infusion
- type
- PRIMARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle