Study of Rituximab in Addition to Glucocorticoid in Pretreated Elderly or Unfit Patients With Chronic B Lymphocytic Leukemia
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
ORR is defined as the proportion of patients achieving CR, CR with MRD negativity (Complete Molecular Remission), nPR and PR
3 months +/- 2 weeks after the last treatment cycle.
Laimonas Griskevicius, MD
Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santariskiu Clinics
Lithuania: State Medicine Control Agency - Ministry of Health