Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia.
- Conditions
- With an annual incidence of 3/100,000 chronic lymphocytic leukaemia is the most common leukaemia in western countries. Pathogenetically and cytomorphologically CLL belongs to the group of low-grade non-Hodgkin's lymphomas. More than 90 % of the cases are derived from B-lymphocytes.MedDRA version: 14.0Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2004-002787-15-CZ
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 817
•B-CLL confirmed according to NCI Working Group criteria [1]
•Binet stage C as well as Binet stage B requiring treatment
All patients must fulfill the criteria of disease requiring treatment. Disease requiring treatment is defined as:
•Binet stage C
•Binet stage B plus at least one of the following signs or symptoms:
- B symptoms (night sweats, weight loss > or = 10% within the previous 6 months, fevers > 38°C or 100.4°F for > or = 2 weeks without evidence of infection) or constitutional symptoms (fatigue)
- Continuous progression (doubling of peripheral lymphocyte count < 6 months AND absolute lymphocyte count > 50 G/l)
- evidence of progressive marrow failure as manifested by the development / worsening of anemia and/or thrombocytopenia
- massive, progressive or painful splenomegaly or hypersplenism
- massive lymph nodes or lymph node clusters (> 10 cm in longest diameter), danger of organ complications through large lymphomas (e.g. vascular compression, e.g. tracheal narrowing) or progressive lymphadenopathy
- Occurrence of symptomatic hyperviscosity problems at leucocyte counts > 200 G/l (symptomatic leucostasis)
•No previous treatment of the CLL by chemotherapy, radiotherapy or immunotherapy.
•Alkaline phosphatase and transaminases = 2 x ULN
•A negative serum pregnancy test one week prior to treatment must be available both for pre-menopausal women and for women who are < 2 years after the onset of menopause.
•Willingness to use contraception for the entire duration of the treatment and 2 months thereafter
•Patient's written informed consent
•Age > or = 18 years
•Life expectancy > 6 months
•ECOG performance status 0-1
•Patient's written informed consent
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 567
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 243
•Stage Binet A
•Clinically significant auto-immune cytopenia, Coombs-positive haemolytic anaemia as judged by the treating physician.
•Active second malignancy currently requiring treatment (except basal cell carcinoma or tumour treated curatively by surgery)
•Pregnancy,and/or nursing
•Concomitant disease requiring prolonged use of glucocorticoids (> 1 month)
•Known hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or any of the study drugs
•CIRS score > 6
•Cerebral dysfunction which makes it impossible to perform chemotherapy
•Transformation to aggressive B-cell malignancy (eg diffuse large cell lymphoma, Richter's syndrome, or prolymphocytic leukaemia) .
•Active bacterial, viral or fungal infection. Although testing for hepatitis B is not mandatory, this should be considered for all patients considered at high risk of hepatitis B infection and in endemic areas. Patients with any serological evidence of current or past hepatitis B infection are excluded unless the serological findings are clearly due to vaccination.
•Total bilirubin > 2 x ULN
•Creatinine clearance < 70 ml/min calculated according to the formula of Cockcroft and Gault
•Any coexisting medical or psychological condition that would preclude participation in the required study procedures.
• Treatment with any other investigational agent, or participating in another clinical trial within 30 days prior to entering this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method