Participant flow

A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma · Source last updated 2016-05-11

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

groups

1. description

   Brentuximab vedotin 1.8 milligram per kilogram (mg/kg), injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.

   id

   FG000

   title

   Brentuximab Vedotin

2. description

   Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 milligram (mg), capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.

   id

   FG001

   title

   Brentuximab Vedotin + Rifampicin

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         6

      type

      Stem Cell Transplant

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         2

      type

      Disease Progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         10

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         10

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with a historical diagnosis of relapsed or refractory classical hodgkin lymphoma (HL) or relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) were enrolled in 1 of 2 treatment groups: Brentuximab vedotin; Brentuximab vedotin + Rifampicin.

recruitment Details

Participants took part in the study at 5 investigative sites in Belgium, Lithuania and Spain from 27 November 2013 to 16 June 2015.

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Preserved source evidence · Not medical advice