Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia.

• Conditions: chronic lymphatic leukaemia; MedDRA version: 14.1Level: 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-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-17
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 817

Inclusion Criteria

• B-CLL confirmed according to NCI Working Group criteria [1] • Binet stage C as well as Binet stage B requiring treatment All patients must fulfil 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 = 10% within the previous 6 months, fevers > 38°C or 100.4°F for = 2 weeks without evidence of infection) or constitutional symptoms (fatigue) – Continuous progression (doubling of peripheral lymphocyte count < 6 months AND absolute lymphocyte count > 50 x109/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 x109/L (symptomatic leucostasis) 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. • 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 = 18 years • Life expectancy > 6 months • ECOG performance status 0-1 * Patients with stage Binet A requiring treatment could be included until July 2004 under the previous version of the protocol, but will not be included in the per protocol analysis.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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 250

Exclusion Criteria

• 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 (e.g. 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 • 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