Participant flow

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL · Source last updated 2023-10-23

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

groups

1. description

   MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.

   id

   FG000

   title

   Treatment (MOR00208, Lenalidomide)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         16

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         8

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         42

      type

      Progressive disease/ Disease relapse

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         81

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         80

      type

      Received MOR00208 + LEN

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      type

      Received MOR00208 Only

   4. achievements

      1. group Id

         FG000

         num Subjects

         8

      type

      Completed: Participants Who Were Still on Treatment at EOS

   5. achievements

      1. group Id

         FG000

         num Subjects

         73

      type

      Not Completed: Participants Who Were no Longer Receiving Treatment at EOS

   6. achievements

      1. group Id

         FG000

         num Subjects

         8

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         73

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

The participants were enrolled into this study at sites in Hungary, Belgium, Czechia, France, Poland, Italy, Germany, Spain, United Kingdom, and the United States.

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Preserved source evidence · Not medical advice