Participant flow

Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients · Source last updated 2024-02-13

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

groups

1. description

   Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).

   id

   FG000

   title

   Main Cohort: Single Dose of CTL019

2. description

   Pediatric B-ALL patients who are very high risk at first relapse.

   id

   FG001

   title

   Cohort 1: Single Dose of CTL019

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         0

      type

      Lack of Efficacy

   3. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         0

      type

      New therapy for study indication

   4. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         1

      type

      Subject/guardian decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         79

      2. group Id

         FG001

         num Subjects

         1

      comment

      Started = Enrolled in All cohorts

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         79

      2. group Id

         FG001

         num Subjects

         1

      type

      Enrolled and Infused

   3. achievements

      1. group Id

         FG000

         num Subjects

         48

      2. group Id

         FG001

         num Subjects

         1

      type

      Discontinued Study Follow-up

   4. achievements

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         0

      comment

      Completed = study follow-up completed

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         48

      2. group Id

         FG001

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

This study was conducted in 11 countries with 23 sites.

recruitment Details

98 patients met the eligibility criteria and apheresis was accepted by the manufacturing facility, 80 patients were infused in this study: 79 in the Main Cohort and 1 in Cohort 1. No patients were infused in Cohort 2. Patients could discontinue the trial after meeting the eligibility criteria and prior to tisagenlecleucel infusion.

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

Preserved source evidence · Not medical advice