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NCT01318317 · OUTCOME

Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE) Detection Above Background

Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma · Source last updated 2026-05-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
CAR copy number/mL
Interval / dispersion
Full Range
Time frame
28 days post T cell infusion

What was measured

Peak expansion of WPRE is expressed in CAR copy number/mL of blood is summarized with median and range

Analysis population: 1 participant in dose level 1 did not have any whole blood samples to analyze. Overall median 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (Cellular Adoptive Immunotherapy Following PBSCT)7

Reported measurements

Source class 1
Values in CAR copy number/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Treatment (Cellular Adoptive Immunotherapy Following PBSCT)280Not reported0925Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        925
        value
        280
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
Peak expansion of WPRE is expressed in CAR copy number/mL of blood is summarized with median and range
dispersion Type
Full Range
groups
  1. 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
MEDIAN
population Description
1 participant in dose level 1 did not have any whole blood samples to analyze. Overall median was reported due to small samples sizes in each dose level.
reporting Status
POSTED
time Frame
28 days post T cell infusion
title
Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE) Detection Above Background
type
PRIMARY
unit Of Measure
CAR copy number/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice