Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) versus Bendamustine and Rituximab (BR) in patients with previously untreated chronic lymphocytic leukaemia - CLL10

GCLLSG - Dept. of Internal Medicine I, University Hospital Cologne0 sites550 target enrollmentAugust 31, 2009

Overview

No summary available.

Registry

who.int

Start Date

August 31, 2009

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

GCLLSG - Dept. of Internal Medicine I, University Hospital 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.
•Requiring treatment is defined as:
•a) •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
•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.
•4\.Any prior chemotherapy and/or radiotherapy and/or immunotherapy, except for prednisolone 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).
•7\.CIRS\-Score \> 6 or a single score of 4 for one organ category.
•8\.Patients with a 17p deletion detected by FISH (these patients will be treated within the CLL2O or CLL2L protocol of the GCLLSG)
•9\.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
•10\.Any prior CLL\-specific chemotherapy and/or radiotherapy and/or immunotherapy, except for prednisolone treatment administered due to very high lymphocyte counts immediately before first FCR or BR treatment.