Participant flow

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a) · Source last updated 2018-09-14

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

groups

1. description

   Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).

   id

   FG000

   title

   Obinutuzumab + Chlorambucil (GClb)

2. description

   Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.

   id

   FG001

   title

   Chlorambucil (Clb)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         33

      2. group Id

         FG001

         num Subjects

         16

      type

      Adverse Events or Intercurrent Illness

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         8

      type

      Disease Progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrew Consent

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         6

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Administrative/Other

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Refused Treatment/Did Not Cooperate

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         5

      type

      Insufficient Therapeutic Response

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Violation of Selection Criteria

   9. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Did Not Receive Treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         238

      2. group Id

         FG001

         num Subjects

         118

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         236

      2. group Id

         FG001

         num Subjects

         116

      type

      Received Study Drug

   3. achievements

      1. comment

         Completed=Completed treatment.

         group Id

         FG000

         num Subjects

         190

      2. group Id

         FG001

         num Subjects

         78

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         48

      2. group Id

         FG001

         num Subjects

         40

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

589 patients were randomized to 1 of 3 treatment groups in 2:2:1 ratio: GClb (n=238), RClb (n=233) or Clb (n=118) in Stage 1 and an additional 192 randomized to GClb or RClb in Stage 2 \[NCT02053610\]. Stage 1 was divided for analysis into: Stage 1a (GClb vs Clb) n=356 reported here and Stage 1b (RClb vs Clb) \[NCT01998880\] reported separately.

recruitment Details

787 patients were enrolled in the study. Following a 6 patient safety run-in prior to randomization, 781 patients were randomized.

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Preserved source evidence · Not medical advice