Untreated chronic lymphocytic leukaemia (B-CLL) MedDRA version: 9.1 Level: LLT Classification code 10003946 Term: B-Lymphocytic, CLL (Kiel Classification)
Conditions
Interventions
Trade Name: Revlimid
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lenalidomide
Other descriptive name: 3-(4´aminoisoindoline-l´-one)-1-piperidine-2,6-dione
Concentration unit: mg milligram(
Sponsors
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • B-CLL (as determined by CD23+, CD5+, CD19+) • Treatment indication as defined by the NCI Workshop criteria • Age =18 • ECOG performance status 0-2 • No previous treatment of the CLL by chemotherapy, radiotherapy (except localized radiotherapy of 1 lymphatic area) or immunotherapy • Life expectancy > 6 months (except prognosis due to high risk CLL) • Patient's written informed consent • Women of non-childbearing potential, or women of childbearing potential with adequate contraception. Men using effective contraception. 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
Exclusion criteria: • Active bacterial, viral or fungal infection • Positivity for HIV, Hepatitis B or C • Reduced organ functions and bone marrow dysfunction not due to CLL • Creatinine clearance of below 30 ml/min • Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent. • Patients with medical co-morbid conditions that would require long term use (> 1 month) of systemic corticosteroids during study treatment • Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina • Other known co-morbidity with the potential to dominate survival • Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter's syndrome, or prolymphocytic leukemia (PLL) • Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or any of the applied drugs • Pregnant or breast feeding women • Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the maximum tolerated dose of lenalidomide in combination with fludarabine/ rituximab therapy.;Secondary Objective: • To evaluate the safety profile of lenalidomide combined with fludarabine/ rituximab in the treatment of patients with previously untreated B-CLL. • To evaluate the safety profile of lenalidomide/ rituximab combination therapy in the treatment of patients with previously untreated B-CLL. • To determine the efficacy in terms of response rates for lenalidomide combined with fludarabine/ rituximab. • To determine the efficacy in terms of response rates for the maintenance therapy lenalidomide/ rituximab. • To determine response rates in all phases by 4-colour flow cytometric MRD analysis • To identify risk factors (FISH cytogenetics, CD38/Zap-70 expression, mutation status) • To define clonal evolution by use of longitudinal FISH cytogenetics • To provide longitudinal definition of T cell subsets (including prognostic EM T cells and Treg cells);Primary end point(s): Maximum tolerated dose of lenalidomide | — |
Countries
Austria
Outcome results
None listed