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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphocytic Leukemia, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab 15 mg/kg

Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Bevacizumab was supplied as a sterile liquid in single-use vials.

Interventions

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Bevacizumab

Bevacizumab was supplied as a sterile liquid in single-use vials.

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No