Rituximab in Pretreated Elderly or Unfit B-CLL Patients

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Dr. Med. Laimonas Griskevicius
• Treatments: Glucocorticoids; Methylprednisolone; Rituximab

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.