Status:
COMPLETED
A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Lymphocytic Leukemia, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This single arm study evaluated the bone marrow response, safety, and tolerability of 6 months treatment with Avastin (bevacizumab) monotherapy in patients with chronic lymphocytic leukemia. Patients ...
Eligibility Criteria
Inclusion
- Male or female patients, ≥ 18 years of age.
- B-chronic lymphocytic leukemia not yet requiring treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- No previous treatment of chronic lymphocytic leukemia (CLL) by chemotherapy, radiotherapy, or immunotherapy.
- Life expectancy \> 6 months.
Exclusion
- Central nervous system (CNS) involvement by lymphoma or any evidence of spinal cord compression.
- Computed tomography (CT) scan based evidence of tumor invading major blood vessels.
- Gastrointestinal (GI) tract involvement by CLL.
- Active viral, bacterial, or fungal infection.
- Uncontrolled hypertension, cerebrovascular accident/stroke (≤ 6 months prior to randomization), myocardial infarction (≤ 6 months prior to randomization), unstable angina (≥ New York Heart Association (NYHA) Grade IV), thrombosis within 6 months before enrollment, NYHA Grade II congestive heart failure, or serious cardiac arrhythmia requiring ongoing medication.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00754650
Start Date
September 1 2008
End Date
March 1 2009
Last Update
June 26 2014
Active Locations (1)
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1
Salzburg, Austria, 5020