Randomized phase III trial comparing early treatment withfludarabine, cyclophosphamide + rituximab versus deferredtreatment in untreated Binet stage A patientswith high risk of progressionCLL 7 protocol of the GCLLSG and FCGC

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

1) Established diagnosis of B-CLL by NCI criteria (Cheson et al., 1996). Diagnosis will
be retrospectively confirmed by an expert review committee. Immunophenotyping
should be stored in list mode and one stained blood smear available.
2) Binet stage A.
3) First diagnosis within 12 months before inclusion in study.
4) Start of therapy possible within 28 days after completed risk stratification/
randomization.
5) No prior chemotherapy, radiation or antibody treatment.
6) Age > 18 years.
7) Life expectancy > 6 months.
8) ECOG performance status 0 - 2.
9) Written informed consent of patient and treating physician.
10) All parameters for risk stratification present.
11) Willingness to accept contraception if randomized to cohort I for the
duration of therapy and 12 months thereafter.
12) Negative serum pregnancy test one week prior to treatment for premenopausal
women.
13) Ability to understand the protocol.
14) Possibility of follow up.
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) Age < 18 years.
2) ECOG performance status > 2.
3) Clinically apparent autoimmune cytopenia, in particular antiglobulin test positive
hemolytic anemia (positive antiglobulin test without anemia is not an exclusion
criterion)
4) Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease
other than B-CLL prior to the study
5) Medical condition requiring the prolonged (estimated to be more than one month) use
of oral corticosteroids
6) History of anaphylactic reaction following exposure to humanized monoclonal
antibodies
7) Patients with active bacterial, viral or fungal infection
8) Known infection with HIV, Hepatitis B or C
9) Treatment with any other investigational agent or participating in another trial within
30 days prior to entering this study
10) Pregnancy and/or nursing
11) Concurrent severe diseases which exclude the administration of therapy
o heart insufficiency NYHA grade III/IV, LVEF < 50% and or RF <30%,
myocardial infarction within the past 6 months prior to study
o severe chronic obstructive lung disease with hypoxemia
o severe diabetes mellitus
o hypertension difficult to control
o impaired renal function with creatinine clearance < 70 ml/min according to the
formula of Cockroft and Gault
o Serum bilirubin > 2 x ULN
o Cerebral dysfunction or any other coexisting medical or psychological condition
that woud preclude participation in the required study procedures
12) Transformation to aggressive B cell malignancy (i.e. diffuse large cell
lymphoma,
Richter’s syndrome or prolymphocytic leukemia

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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