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 - CLL10

GCLLSG - Dept. of Internal Medicine I, University Hospital Cologne0 sites550 target enrollmentAugust 10, 2010

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: patients (age 18 years or older) with chronic lymphocytic leukemia: Stage Binet C or stage Binet B and A requiring treatment
Sponsor: GCLLSG - Dept. of Internal Medicine I, University Hospital Cologne
Enrollment: 550
Status: Active, not recruiting
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

August 10, 2010

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 Binet A plus at least one of the following 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 \> 5 x 10\.9 (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
•b) Binet stage A with severe B\-Symptoms (night sweats, weight loss \>\=10% within the previous 6 months, fevers \> 38°C or 100\.4°F for ³ 2 weeks without evidence of infection).

•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 \> and \= 1,1 mg/dl.
•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\. History of anaphylaxis following exposure to monoclonal antibodies or any of the study drugs.
•8\. Active bacterial, viral or fungal infection.
•9\. Medical condition requiring prolonged use of oral corticosteroids (\> 1 month).
•10\. Cerebral dysfunction, legal incapacity.