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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Overall Response Rate
Overall response rate (ORR) is defined according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2008) guidelines, as the proportion of patients achieving complete response (CR), CR with minimal residual disease (MRD) negativity (complete molecular remission), nodular partial remission (nPR) and partial response (PR).
Time frame: 3 months +/- 2 weeks after the last treatment cycle.
Progression Free Survival
Progression free survival (PFS) will be defined as the interval from entry into the study to disease progression or death.
Time frame: up to 12 months
Number of Participants With Adverse Events
Adverse events NCI CTCAE, version 4.0. Hematological toxicity was evaluated according to IWCLL 2008 guidelines.
Time frame: 6 months.
Overall Survival
Overall survival (OS) will be defined as the interval from date of randomization until the date of death from any cause, assessed up to 100 months.
Time frame: from date of randomization until the date of death from any cause, assessed up to 100 months
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