Trial information
A Proof of Concept Study of the Safety, Tolerability and Efficacy of Avastin (Bevacizumab) in Patients With Chemonaive Chronic Lymphocytic Leukemia (CLL)
Status: Recruiting
Protocol number: ML21206
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Avastin in chronic lymphocytic leukemia: proof of concept
Brief summary: This single arm study will evaluate the bone marrow response, safety and tolerability of six months treatment with Avastin monotherapy in patients with chronic lymphocytic leukemia. Patients will receive 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with 6 months of follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 10.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Lymphocytic Leukemia, Chronic
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. Bone marrow response after 6 months of Avastin Time frame: Week 12 and Week 24
Key secondary outcomes: 1. Clinical efficacy (complete response, partial response); molecular complete response; toxicity of treatment; progression-free survival; VEGF levels in serum and bone marrow. Time frame: Week 12 and Week 24
Inclusion criteria:
- male or female patients, >=18 years of age;
- B-chronic lymphocytic leukemia not yet requiring treatment;
- ECOG performance status 0-2;
- no previous treatment of CLL by chemotherapy, radiotherapy or immunotherapy;
- life expectancy >6 months.
Exclusion criteria:
- CNS involvement by lymphoma or any evidence of spinal cord compression;
- CT scan based evidence of tumor invading major blood vessels;
- GI tract involvement by CLL;
- active viral, bacterial or fungal infection;
- uncontrolled hypertension, CVA/stroke (<=6 months prior to randomization), myocardial infarction (<=6 months prior to randomization), unstable angina (>=NYHA Grade IV), thrombosis within 6 months before enrollment, NYHA Grade II CHF or serious cardiac arrhythmia requiring ongoing medication.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 09/22/2008
Date last updated: 12/19/2008
Link to trial result
This trial is being conducted at the following locations:
Austria
