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Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma · Source last updated 2026-08-28

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

groups

1. description

   Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.

   id

   FG000

   title

   Arm A (Ibrutinib, Rituximab)

2. description

   Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.

   id

   FG001

   title

   Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         279

      2. group Id

         FG001

         num Subjects

         0

      type

      Still on treatment

   2. reasons

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         38

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         3

      type

      Disease progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         8

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Complication

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Non-protocol therapy

   8. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Second primary cancer

   9. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Insurance

   10. reasons

       1. group Id

          FG000

          num Subjects

          2

       2. group Id

          FG001

          num Subjects

          0

       type

       Wound infection/healing

   11. reasons

       1. group Id

          FG000

          num Subjects

          3

       2. group Id

          FG001

          num Subjects

          0

       type

       Missed appointment

   12. reasons

       1. group Id

          FG000

          num Subjects

          2

       2. group Id

          FG001

          num Subjects

          17

       type

       Never started treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         354

      2. group Id

         FG001

         num Subjects

         175

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         105

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         354

      2. group Id

         FG001

         num Subjects

         70

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

The study was activated on January 31, 2014 and closed to accrual on June 9, 2016. A total of 529 patients were enrolled on this study.

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Preserved source evidence · Not medical advice