Participant flow

Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2017-08-18

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

groups

1. description

   Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.

   id

   FG000

   title

   Blinatumomab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Ongoing in core study

   2. reasons

      1. group Id

         FG000

         num Subjects

         46

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         43

      type

      Progressive disease

   4. reasons

      1. group Id

         FG000

         num Subjects

         32

      type

      Adverse Event

   5. reasons

      1. group Id

         FG000

         num Subjects

         23

      type

      Disease relapse

   6. reasons

      1. group Id

         FG000

         num Subjects

         14

      type

      Lack of Efficacy

   7. reasons

      1. group Id

         FG000

         num Subjects

         7

      type

      Death

   8. reasons

      1. group Id

         FG000

         num Subjects

         7

      type

      Withdrawal by Subject

   9. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Protocol Violation

   10. reasons

       1. group Id

          FG000

          num Subjects

          3

       type

       Other

   milestones

   1. achievements

      1. comment

         Participants enrolled during the first 3 stages of the study

         group Id

         FG000

         num Subjects

         189

      type

      STARTED

   2. achievements

      1. comment

         Completed 5 cycles of treatment; Data as of the time of the data cut-off date (10 October 2013).

         group Id

         FG000

         num Subjects

         10

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         179

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Two hundred twenty-five participants enrolled in the study overall. Results below include data for 189 participants enrolled in the first 3 stages of the study (the primary analysis set). An additional 36 participants enrolled in the Additional Evaluation Cohort are not reported here as the study is ongoing and data collection has not completed.

recruitment Details

This study was open to adult patients with relapsed / refractory B-precursor acute lymphoblastic leukemia (ALL). The study protocol originally used a Simon 2-stage design and was subsequently expanded to include a third stage. Protocol amendment 4 added an additional cohort of participants for central nervous system evaluations.

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Preserved source evidence · Not medical advice