Chronic Lymphocytic Leukemia
Conditions
Sponsors
Roche Austria GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient's written informed consent • B-CLL (as determined by CD23+, CD5+, CD19+, CD20+) • Treatment not yet indicated as defined by NCI Workshop Criteria, but with =1 risk factors (unfavourable molecular cytogenetics [17p and/or 11q and/or trisomy 12]; increased CD-38 level; increased ZAP70 expression; unmutated IgVH gene; or predicted lymphocyte doubling time shorter than 12 months) • Signs of advanced tumor mass or disease dynamics (fatigue or weight loss below NCI-definition, increase in bone marrow infiltration of more than 20% or absolute bone marrow infiltration rate of greater 70%, cytopenias due to splenomegaly below NCI criteria, lymph nodes above 3 cm or progressive lymphadenopathy below 50% in 6 month, leukocytosis greater than 100.000/µl) • Age =18 • ECOG performance status 0-2 • No previous treatment of the CLL by chemotherapy, radiotherapy or immunotherapy • Life expectancy > 6 months • Patient using a reliable means of contraception (e.g. physical barrier, contraceptive pill or patch, spermicide and barrier, or IUD) for the duration of the treatment including 1 year thereafter • Adequate renal function as documented by: - a serum creatinine level =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Uncontrolled viral, bacterial or fungal infection • History of solid organ transplantation • Pregnant or nursing females • CNS involvement by CLL or any evidence of spinal cord compression. Brain CT/MRI is only mandatory (within 4 weeks prior to enrolment) in case of clinical suspicion of CNS involvement by CLL. • CT scan based evidence of tumor invading major blood vessels (putting patients at risk for bleeding during study treatment) • Gastrointestinal tract involvement by CLL (test only upon clincal suspicion) • Prior malignancy (except adequately treated basal cell carcinoma of the skin, in situ cervical cancer, or any other cancer for which the patient has been in remission for at least 5 years) • Known hypersensitivity to study drug or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies) • Seizures requiring permanent anticonvulsant therapy • Severe chronic obstructive pulmonary disease with hypoxemia • Uncontrolled diabetes mellitus • Uncontrolled hypertension, CVA/stroke (= 6 months prior to enrolment), myocardial infarction (= 6 months prior to enrolment), unstable angina (= NYHA Grade IV), thrombosis within 6 months before enrolment, NYHA = Grade II CHF, or serious cardiac arrhythmia requiring ongoing medication • Clinically significant, active peripheral vascular disease, serious non healing wound/ulcer, bone fracture, bleeding diathesis (history or evidence of inherited bleeding diathesis) or coagulopathy • Major surgery, open biopsy or trauma within 28 days before enrolment (lymph node biopsies are not considered major surgery), or the need for major surgery during the course of study treatment • History of active ulcer (within 1 year prior to enrolment), abdominal fistula, gastrointestinal perforation, or intra abdominal abscess or concurrent therapy for treatment/prevention of ulcer • Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational therapeutic study • Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or patient at high risk from treatment complications • Any co-existing medical or psychological condition that would compromise ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Bone marrow response (change in percentage of infiltration) after 6 months of Bevacizumab;Secondary Objective: Clinical complete response, partial response, nodal partial response rate Molecular complete response Progression Free Survival Time to next treatment Safety and Toxicity Scientific accompanying programme;Primary end point(s): Bone marrow response after 6 months of Bevacizumab | — |
Countries
Austria
Outcome results
None listed