B-Cell Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Study of Rituximab in Addition to Glucocorticoid in Pretreated Elderly or Unfit Patients With Chronic B Lymphocytic Leukemia
The study will test the efficacy rituximab in addition to glucocorticoids for the treatment of B-CLL in elderly or unfit patients.
Patient Population: Pretreated patients with symptomatic B-CLL 18-64 years of age with poor
performance status or >/=65 years of age with any performance status.
Treatment: Up-to 4 cycles of glucocorticoid (Methylprednisolone or Dexamethasone) and
Rituximab every 21 day.
Study Duration: The study period for each subject is expected to be 21 months. Subjects will
receive up-to 4 cycles of IV infusion of Rituximab and Glucocorticoid. Maximum duration of
treatment is expected to be 6 months. Subjects will complete scheduled visits not later than
Study Month 21, thereafter they will enter into the long-term follow-up period. Subjects will
be followed every 3 months for disease progression, initiation of subsequent leukemia
treatment or survival.
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