Participant flow

A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma · Source last updated 2017-10-11

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

groups

1. description

   Participants with previously untreated, cluster of differentiation (CD) 20-positive diffuse large B-cell lymphoma (DLBCL) received up to 8 cycles of rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 milligrams per meter-squared (mg/m\^2) via IV infusion; subsequent doses were given as 1400 milligrams (mg) via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved complete response (CR) or complete response unconfirmed (CRu) after 4 cycles, but all participants received a full 8 cycles of rituximab.

   id

   FG000

   title

   Rituximab Subcutaneous (SC)

2. description

   Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.

   id

   FG001

   title

   Rituximab Intravenous (IV)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         14

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      type

      Protocol Violation

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Treatment Failure

   4. reasons

      1. group Id

         FG000

         num Subjects

         69

      2. group Id

         FG001

         num Subjects

         34

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         3

      type

      Stable or Progressed Disease

   6. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         16

      type

      Lost to Follow-up

   7. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         1

      type

      Lack of Compliance

   8. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         5

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         369

      2. group Id

         FG001

         num Subjects

         203

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         230

      2. group Id

         FG001

         num Subjects

         125

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         139

      2. group Id

         FG001

         num Subjects

         78

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 662 individuals were screened for entry into the study, and 86 failed the screening procedure. Overall, 576 participants were randomized; 572 received treatment and were included in the analyses.

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Preserved source evidence · Not medical advice