Participant flow

Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) · Source last updated 2024-03-05

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

groups

1. description

   Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh\*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive SOC therapy for an additional 12 months.

   id

   FG000

   title

   Standard of Care Chemotherapy

2. description

   Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh\*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles.

   id

   FG001

   title

   Blinatumomab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         14

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      Sponsor Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         85

      2. group Id

         FG001

         num Subjects

         160

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         134

      2. group Id

         FG001

         num Subjects

         271

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         109

      2. group Id

         FG001

         num Subjects

         267

      type

      Received Treatment

   3. achievements

      1. comment

         Indicates participants continuing study at time of data cut-off

         group Id

         FG000

         num Subjects

         33

      2. comment

         Indicates participants continuing study at time of data cut-off; 22 were receiving treatment

         group Id

         FG001

         num Subjects

         93

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         101

      2. group Id

         FG001

         num Subjects

         178

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants were randomized in a 2:1 ratio to either blinatumomab or standard of care (SOC) chemotherapy regimens. Randomization was stratified by age (\< 35 years vs ≥ 35 years), prior salvage therapy (yes vs no), and prior allogeneic hematopoietic stem cell transplantation (HSCT) (yes vs no) as assessed at the time of consent.

recruitment Details

This study was conducted at 101 centers in 21 countries in Asia, Australia, Europe, and Latin and North America. The first participant was enrolled on 03 January 2014 and treated on 06 January 2014. The last participant enrolled on 25 September 2015 and the data cutoff date for this report was 04 January 2016.

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Preserved source evidence · Not medical advice