Phase 2 Completed N=2 Treatment

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

Lymphocytic Leukemia, Chronic

Source: ClinicalTrials.gov NCT00754650 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcomePrimary: Bone Marrow Response — -20.0; -20.0 Percentage of infiltration

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Bone Marrow Response	-20.0; -20.0	—
SECONDARY Best Overall Response (BOR)	0.0; 0.0; 50.0; 50.0; 0.0; 0.0	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00754650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.