Participant flow

Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients · Source last updated 2024-04-18

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

groups

1. description

   Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.

   id

   FG000

   title

   Tisagenlecleucel - Main Cohort

2. description

   Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.

   id

   FG001

   title

   Tisagenlecleucel Cohort A

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         12

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         1

      type

      Progressive disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         0

      type

      Subject decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         0

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         99

      2. group Id

         FG001

         num Subjects

         16

      comment

      Started = Infused

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         3

      comment

      Completed = Study follow-up completed

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         73

      2. group Id

         FG001

         num Subjects

         13

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

After informed consent/assent was obtained, and prior to infusion, participants underwent a routine lymphodepleting therapy, 14 to 5 days before CTL019 infusion. There were 27 centers across 10 countries for this trial.

recruitment Details

115 participants were infused in this study: 99 in the Main Cohort and 16 in Cohort A.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice