Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FC-R) versus chemotherapy with Fludarabine and Cyclophosphamide (FC) alone in patients with previously untreated chronic lymphocytic leukaemia.

F. Hoffmann-La Roche Ltd0 sites817 target enrollmentJanuary 10, 2005

Overview

No summary available.

Registry

who.int

Start Date

January 10, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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.