A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)

Arms (2)

1. type

   EXPERIMENTAL

   label

   A

   interventionNames

   1. Drug: bendamustine
   2. Drug: rituximab [MabThera/Rituxan]

2. type

   EXPERIMENTAL

   label

   B

   interventionNames

   1. Drug: chlorambucil
   2. Drug: rituximab [MabThera/Rituxan]

Primary outcomes (1)

1. measure

   Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy

   timeFrame

   At least 2 months after completion of therapy (up to 32 weeks)

   description

   The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes less than (\<) 4 times 10\^9 cells per liter (cells/L); absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to chronic lymphocytic leukemia (CLL) involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils at least (\>/=) 1.5 times 10\^9 cells/L, platelets greater than (\>) 100 times 10\^9 cells/L, and hemoglobin \> 11.0 grams per deciliter (g/dL); normocellular bone marrow (BM) aspirate with \< 30 percent (%) lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.