Participant flow

Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2020-02-10

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

groups

1. description

   Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment. Participants suitable for allogeneic hematopoietic stem cell transplant (HSCT) after treatment with at least 1 cycle of blinatumomab may have undergone allogeneic HSCT instead of receiving further cycles with blinatumomab.

   id

   FG000

   title

   Blinatumomab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         67

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         116

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         48

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         68

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

This study was open to adults with a diagnosis of minimal residual disease (MRD; ≥ 10-³ leukemic cells) -positive B-precursor acute lymphoblastic leukemia (ALL) who were in complete hematologic remission.

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Preserved source evidence · Not medical advice