Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) versus Bendamustine and Rituximab (BR) in patients with previously untreated chronic lymphocytic leukemia

niversity of Cologne0 sites550 target enrollmentApril 28, 2008

Overview

No summary available.

Registry

who.int

Start Date

April 28, 2008

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Cologne

•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 \< 6 months)
•\-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)or progressive or symptomatic lymphadenopathy

•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 \<70ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured after 24h\-urine collection. Creatinine Clearance is to be calculated only in patients with serum creatinine \= 1\.1 mg/dl.
•4\.Any prior CLL specific\-chemotherapy and/or radiotherapy and/or immunotherapy (except for prednisolon treatment administered due to very high lymphocyte counts immediately before first FCR or BR treatment).
•5\.Patients who have progressed with more aggressive B\-cell cancers such as Richter’s syndrome.
•6\.Active secondary malignancy requiring treatment (except basal cell carcinoma or malignant tumour curatively treated by surgery). or successfully treated secondary malignancies in complete remission more than 5 years before enrollment ).
•7\.History of anaphylaxis following exposure to monoclonal antibodies.
•8\.Active bacterial, viral or fungal infection.
•9\.Medical condition requiring prolonged use (defined as \> 1 month) of oral corticosteroids.
•10\.Cerebral dysfunction, legal incapacity.