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

NCT00754650 | Completed Phase 2 Results

• 2 other identifiers: ML212062007-004824-19
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Lymphocytic Leukemia, Chronic

Outcome Measures

Primary Outcomes (1)

• Bone Marrow Response

  Bone marrow response was defined as the change in percentage of infiltration at the interim staging (after 4 cycles of treatment) and the end of treatment.

  Baseline to the end of treatment (up to 24 weeks)

Secondary Outcomes (1)

• Best Overall Response (BOR)

  Baseline to the end of treatment (up to 24 weeks)

Study Arms (1)

Bevacizumab 15 mg/kg

EXPERIMENTAL

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

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

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

Also known as: Avastin

Bevacizumab 15 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: June 26, 2014
• Results First Posted: June 26, 2014

Record last verified: 2014-05

Locations

AU (1)