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

Phase 1

• Conditions: Patients with previously untreated chronic lymphocytic leukaemia; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2007-007587-21-DK
• Lead Sponsor: GCLLSG - Dept. of Internal Medicine I, University Hospital Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-31
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

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
4.World Health Organization performance status of 0-2.
5.Life expectancy> 6 months.
6.Adequate liver function as indicated by a total bilirubin, AST, and ALT =2 the institutional ULN value, unless directly attributable to the patient’s tumor.
7.Willingness of fertile male and female patients to use an highlyeffective contraceptive method with a Pearl-Index < 1 (such as implants, injectables, oral contraceptives in combincation with an other contraceptive method, some IUDs, sexual abstinence or vasectomised partner) while on study treatment and for a minimum of six months following study therapy
8.Signed, written informed consent.
9.Patient is a) male b) female and ? 2 years after the onset of menopause c) female and < 2 years after the onset of menopause and has a negative serum pregnancy test one week prior treatment.
10.Negative serological Hepatitis B test, negative testing of Hepatitis C RNA, negative HIV test within 6 weeks prior to registration.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.
11.Patients who have progressed with more aggressive B-cell cancers such as Richter’s syndrome.
12.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 ).
13.Participation in any other clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified