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

Phase 1

• Conditions: patients (age 18 years or older) with chronic lymphocytic leukemia: Stage Binet C or stage Binet B and A requiring treatment; MedDRA version: 9.1Level: LLTClassification code 10009310Term: C

• Registration Number: EUCTR2007-007587-21-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-28
• Last Update Posted: 12 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
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
Attention:
marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for protocol therapy.
4.WHO performance status of 0-2.
5.Life expectancy = 6 months.
6.Adequate liver function as indicated by a total bilirubin, AST, and ALT =2x the institutional ULN value, unless directly attributable to the patient’s tumor.
7.Willingness of fertile Male and female patients to use an highly effective contraceptive method with a Pearl-Index < 1 (such as implants, injectables, oral contraceptives in combination 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. 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.
11.Pregnant or nursing women, fertile men or women of childbearing potential not using adequate contraception.
12.Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
13.Participation in any other clinical trial

Study & Design

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