Participant flow

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.

groups

1. description

   Participants with Epstein-Barr virus positive (EBV+) posttransplant lymphoproliferative disorders (PTLD) hematopoietic cell transplant (HCT) who were relapse/refractory (R/R) to rituximab received IV infusion of tabelecleucel (Tab-cel) 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

   FG000

   title

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

2. description

   Participants with EBV+PTLD solid organ transplant (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

   FG001

   title

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

3. description

   Participants with EBV+ acquired immunodeficiency (AID) lymphoproliferative disorder (LPD) 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

   FG002

   title

   EBV+ AID-LPD (Tab-cel Only)

4. description

   Participants with EBV+ leiomyosarcoma (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

   FG003

   title

   EBV+ LMS (Tab-cel Only)

5. description

   Participants with EBV+ nasopharyngeal carcinoma (NPC) 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

   FG004

   title

   EBV+ NPC (Tab-cel Only)

6. description

   Participants with EBV+PTLD HCT who were R/R to rituximab or rituximab naive received donor-derived EBV cytotoxic T lymphocyte (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

   FG005

   title

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

7. description

   Participants with EBV+PTLD SOT 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

   FG006

   title

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

8. description

   Participants with EBV+ 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

   FG007

   title

   EBV+ Viremia (EBV-CTLs Only)

9. description

   Participants with EBV+ primary immunodeficiency (PID) LPD received IV infusion of tabelecleucel or 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

   FG008

   title

   EBV+PID-LPD (Tab-cel or EBV-CTLs Only)

10. description

    Participants with EBV+ lymphoma received IV infusion of tabelecleucel or 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

    FG009

    title

    EBV+ Lymphoma (Tab-cel or EBV-CTLs Only)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         13

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         1

      10. group Id

          FG009

          num Subjects

          1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      type

      Other

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         1

      10. group Id

          FG009

          num Subjects

          1

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      type

      Adverse Event

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         23

      7. group Id

         FG006

         num Subjects

         2

      8. group Id

         FG007

         num Subjects

         6

      9. group Id

         FG008

         num Subjects

         2

      10. group Id

          FG009

          num Subjects

          2

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         8

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         4

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         15

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         2

      9. group Id

         FG008

         num Subjects

         2

      10. group Id

          FG009

          num Subjects

          2

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 58 participants were treated. However, 1 participant was analyzed in 2 different arms due to treatment. This participant was counted in only 1 arm for Participant Flow results and was counted in each arm for Outcome Measures.

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

Preserved source evidence · Not medical advice