Treated Elderly Patients with Chronic B Lymphocytic Leukemia or patients with underlying pathology MedDRA version: 15.1 Level: LLT Classification code 10003948 Term: B-Lymphocytic, CLL (Kiel Classification) refractory System Organ Class: 100000004864 MedDRA version: 15.1 Level: LLT Classification code 10003947 Term: B-Lymphocytic, CLL (Kiel Classification) recurrent System Organ Class: 100000004864
Conditions
Interventions
Trade Name: MabThera
Product Name: Rituximab
Product Code: Rtx
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMABUM
CAS Number: 174722-31-7
Concentration unit: m
Sponsors
Vilnius University Hospital Santariskiu Clinics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The diagnosis of CD20 positive chronic B lymphocytic leukemia (B-CLL) confirmed by biopsy or flow-cytometry. 2. 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: 1. Constitutional symptoms: 1.1. Weight loss > 10% within the previous 6 months; 1.2. Fatigue (e. g. WHO performance status = 2); 1.3. Fever =38C = 2 weeks without evidence of infection; 1.4. Night sweats for more than 1 month without evidence of infection. 2. Evidence of progressive marrow failure as manifested by development of, or worsening of, anemia and/or thrombocytopenia 3. Autoimmune hemolysis and / or thrombocytopenia poorly responsive to corticosteroid therapy. 4. Massive (i. e. = 6 cm bellow left costal margin) or progressive or symptomatic splenomegaly. 5. Massive lymphadenopathy or conglomerates (i. e., = 10 cm in largest diameter) or progressive or symptomatic lymphadenopathy. 6. 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 30x109/L LDT should not be used as a single parameter to define atreatment 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. 3. Either of the following: 3.1. 18 years of age or older with impaired performance status (CIRS>6) and /or 3.2. 65 years of age or older with any performance status. 4. Signed informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Intolerance to exogenous protein or known severe reaction to the administration of Rituximab. 2. Active infection. 3. Cancer radiotherapy, biological therapy or chemotherapy within 3 weeks prior to Study Day 1. 4. TBC or fungal infection within the past 6 months even if adequately controlled by treatment. 5. Severe organ deficiency preventing the participation in the study. 6. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1. 7. Active peptic ulcer. 8. Inadequately controlled diabetes mellitus. 9. Suspected or confirmed B-CLL CNS disease. 10. Known to be HIV positive. 11. Difficult to control, uncooperative patients. 12. Allergic disorders in need of chronic glucocorticoid therapy. 13. Other oncological diseases requiring active treatment (except hormonal therapy). 14. Pregnancy and breastfeeding. 15. Patients of reproductive potential who are not using effective methods of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the clinical benefit of dose intensive Rituximab in addition to Glucocorticoid in terms of response rate.;Secondary Objective: To determine progresion free and overall survival. To characterize the safety profile. To assess health related quality of life.;Primary end point(s): Overall response rate (ORR);Timepoint(s) of evaluation of this end point: 2-3 months after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival (PFS), Overall survival (OS);Timepoint(s) of evaluation of this end point: 12 months after the end of treatment | — |
Countries
Lithuania
Contacts
Public ContactTadas Zvirblis
Vilnius University Hospital Santariskiu Clinics
Outcome results
None listed