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NCT00002663 · OUTCOME

Objective Response Rate (ORR)

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 251.1 months after Day 1 dose

What was measured

The ORR is defined as percentage of participants with best overall response of complete remission/response (CR) or partial remission/response (PR) based on investigator's assessment. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR is complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel; and PR is a 50 % or greater reduction in the size of all lymphomatous lesions as determined by computed tomography (CT) or magnetic resonance imaging (MRI) measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR is clearance of EBV without subsequent development of EBV+ LPD; and PR is at least a 10-fold decrease in EBV DNA levels.

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-CTL 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)63.6Not reported30.889.1Not reported
EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only)50.0Not reported6.893.2Not reported
EBV+ LMS (Tab-cel Only)0Not reported052.2Not reported
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)43.5Not reported23.265.5Not reported
EBV+ Viremia (EBV-CTLs Only)57.1Not reported18.490.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.8
        upper Limit
        89.1
        value
        63.6
      2. group Id
        OG001
        lower Limit
        6.8
        upper Limit
        93.2
        value
        50.0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        52.2
        value
        0
      4. group Id
        OG003
        lower Limit
        23.2
        upper Limit
        65.5
        value
        43.5
      5. group Id
        OG004
        lower Limit
        18.4
        upper Limit
        90.1
        value
        57.1
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
The ORR is defined as percentage of participants with best overall response of complete remission/response (CR) or partial remission/response (PR) based on investigator's assessment. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR is complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel; and PR is a 50 % or greater reduction in the size of all lymphomatous lesions as determined by computed tomography (CT) or magnetic resonance imaging (MRI) measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR is clearance of EBV without subsequent development of EBV+ LPD; and PR is at least a 10-fold decrease in EBV DNA levels.
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-CTL 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 251.1 months after Day 1 dose
title
Objective Response Rate (ORR)
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice