A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia

Roche

Status and phase

Completed

Phase 2

Conditions

Lymphocytic Leukemia, Chronic

Treatments

Drug: Bevacizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00754650

2007-004824-19 (EudraCT Number)

ML21206

Details and patient eligibility

About

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 received 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with 6 months of follow-up.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.