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NCT00002663 · OUTCOME

OS Rate at 12 Months

Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies · Source last updated 2023-02-13

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From Day 1 through 12 months after Day 1 dose

What was measured

Percentage of participants with OS at 12 months are reported. The OS is defined as the time from the first dose of tabelecleucel or EBV-CTLs to the date of death due to any cause. The OS was estimated using Kaplan-Meier method.

Analysis population: Full analysis set included all participants who received at least one dose of study treatment (tabelecleucel or EBV-CTLs). Results from arms with \<= 3 participants (as shown in the participant flow) are excluded due to the low numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications of this single center study.

Groups in this outcome

EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)

Participants with EBV+ PTLD following HCT who were R/R to rituximab received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.

EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only)

Participants with EBV+PTLD following SOT who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.

EBV+ LMS (Tab-cel Only)

Participants with EBV+ following LMS received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.

EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)

Participants with EBV+PTLD following HCT who were R/R to rituximab or rituximab naive received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.

EBV+ Viremia (EBV-CTLs Only)

Participants with EBV+ following viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)11
EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only)4
EBV+ LMS (Tab-cel Only)5
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)23
EBV+ Viremia (EBV-CTLs Only)7

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)54.5Not reported22.978.0Not reported
EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only)75.0Not reported12.896.1Not reported
EBV+ LMS (Tab-cel Only)100.0Not reported100100Not reported
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)52.2Not reported30.570.0Not reported
EBV+ Viremia (EBV-CTLs Only)85.7Not reported33.497.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.9
        upper Limit
        78.0
        value
        54.5
      2. group Id
        OG001
        lower Limit
        12.8
        upper Limit
        96.1
        value
        75.0
      3. group Id
        OG002
        lower Limit
        100
        upper Limit
        100
        value
        100.0
      4. group Id
        OG003
        lower Limit
        30.5
        upper Limit
        70.0
        value
        52.2
      5. group Id
        OG004
        lower Limit
        33.4
        upper Limit
        97.9
        value
        85.7
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      23
    5. group Id
      OG004
      value
      7
    units
    Participants
description
Percentage of participants with OS at 12 months are reported. The OS is defined as the time from the first dose of tabelecleucel or EBV-CTLs to the date of death due to any cause. The OS was estimated using Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with EBV+ PTLD following HCT who were R/R to rituximab received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
  2. description
    Participants with EBV+PTLD following SOT who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only)
  3. description
    Participants with EBV+ following LMS received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
    id
    OG002
    title
    EBV+ LMS (Tab-cel Only)
  4. description
    Participants with EBV+PTLD following HCT who were R/R to rituximab or rituximab naive received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
    id
    OG003
    title
    EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
  5. description
    Participants with EBV+ following viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
    id
    OG004
    title
    EBV+ Viremia (EBV-CTLs Only)
param Type
NUMBER
population Description
Full analysis set included all participants who received at least one dose of study treatment (tabelecleucel or EBV-CTLs). Results from arms with \<= 3 participants (as shown in the participant flow) are excluded due to the low numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications of this single center study.
reporting Status
POSTED
time Frame
From Day 1 through 12 months after Day 1 dose
title
OS Rate at 12 Months
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice