Rituximab in Pretreated Elderly or Unfit B-CLL Patients
Condition: B-Cell Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Rituximab; Glucocorticoid
Intervention description: 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.
Intervention MeSH terms: Rituximab; Glucocorticoids
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic lymphocytic leukemia, relapsed, elderly or unfit patients, methylprednisolone, rituximab

Summary:

      The study will test the efficacy rituximab in addition to glucocorticoids for the treatment
      of B-CLL in elderly or unfit patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The diagnosis of CD20 positive chronic B lymphocytic leukemia (BCLL) confirmed by
             biopsy or flow-cytometry.

          -  Previously treated patients with stage Rai I-IV and progressive disease (according to
             IWCLL 2008 guidelines).

        Active B-CLL is defined by at least one of the following:

        At least one of the disease related symptoms:

          -  Constitutional symptoms:

          -  Weight loss >10% within the previous 6 months;

          -  Fatigue (e.g., WHO performance status >/=2);

          -  Fever >/=38C >/=2 weeks without evidence of infection;

          -  Night sweats for more than 1 month without evidence of infection.

          -  Evidence of progressive marrow failure as manifested by development of, or worsening
             of, anemia and/or thrombocytopenia

          -  Autoimmune hemolysis and/or thrombocytopenia poorly responsive to corticosteroid
             therapy.

          -  Massive (i.e., >/=6 cm bellow left costal margin) or progressive or symptomatic
             splenomegaly.

          -  Massive lymphadenopathy or conglomerates (i.e., >/=10 cm in largest diameter) or
             progressive or symptomatic lymphadenopathy.

          -  Progressive lymphocytosis with an increase >50% over a 2-month period or an
             anticipated doubling time of less than 6 months. In patients with initial blood
             lymphocyte counts of less than 30x10^9/L LDT should not be used as a single parameter
             to define treatment indication. Marked hypogammaglobulinemia or the development of a
             monoclonal protein in the absence of any of the above criteria for active disease is
             not sufficient for protocol therapy.

          -  Either of the following:

          -  18 years of age or older with impaired performance status (CIRS > 6) and /or

          -  65 years of age or older with any performance status.

          -  Signed informed consent form.

        Exclusion Criteria:

          -  Intolerance to exogenous protein or known severe reaction to the administration of
             Rituximab.

          -  Active infection.

          -  Cancer radiotherapy, biological therapy or chemotherapy within 3 weeks prior to Study
             Day 1.

          -  TBC or fungal infection within the past 6 months even if adequately controlled by
             treatment.

          -  Severe organ deficiency preventing the participation in the study.

          -  Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1.

          -  Active peptic ulcer.

          -  Inadequately controlled diabetes mellitus.

          -  Suspected or confirmed B-CLL CNS disease.

          -  Known to be HIV positive.

          -  Difficult to control, uncooperative patients.

          -  Allergic disorders in need of chronic glucocorticoid therapy.

          -  Other oncological diseases requiring active treatment (except hormonal therapy).

          -  Pregnancy and breastfeeding.

          -  Patients of reproductive potential who are not using effective methods of
             contraception.