patients (age 18 years or older) with chronic lymphocytic leukemia: Stage Binet C or stage Binet B and A requiring treatment MedDRA version: 9.1 Level: LLT Classification code 10009310 Term: CLL
Conditions
Interventions
Trade Name: MabThera
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31-7
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: range
Con
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older. 2. Confirmed diagnosis of B-CLL. 3. Stage Binet C or stage Binet B and A requiring treatment All patients must fulfill the criteria of disease requiring treatment. Disease requiring treatment is defined as: • • Binet stage B or A plus at least one of the following signs or symptoms: - B symptoms (night sweats, weight loss ? 10% within the previous 6 months, fevers > 38°C or 100.4°F for ? 2 weeks without evidence of infection) or constitutional symptoms (fatigue) - progressive lymphocytosis (lymphocytosis is defined as peripheral lymphocyte count > 5x109/l) (increase > 50% over a 2-month period or doubling of peripheral lymphocyte count 10 cm in longest diameter)or progressive or symptomatic lymphadenopathy Attention: 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. 4. WHO performance status of 0-2. 5. Life expectancy = 6 months. 6. Adequate liver function as indicated by a total bilirubin, AST, and ALT =2x the institutional ULN value, unless directly attributable to the patient’s tumor. 7. Willingness of fertile Male and female patients to use an highly effective contraceptive method with a Pearl-Index =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. CIRS-Score > 6. or a single score of 4 for one organ category. 2. Patients with a 17p deletion detected by FISH (these patients will be treated within the CLL2O or CLL2L protocol of the GCLLSG) 3. Creatinine clearance 1 month) of oral corticosteroids. 10. Cerebral dysfunction, legal incapacity. 11. Pregnant or nursing women, fertile men or women of childbearing potential not using adequate contraception. 12. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up. 13. Participation in any other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: the progression free survival (PFS);Secondary Objective: the duration of remission the event free survival (EFS) the overall survival (OS) MRD, complete response rates and partial remission rates response rates and survival times in biological subgroups rates of toxicities quality of life;Primary end point(s): the progression free survival (PFS). | — |
Countries
Austria, Czech Republic, Denmark, Germany
Outcome results
None listed