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

Sponsor
Hoffmann-La Roche
Study ID
NCT00754650
Phase
PHASE2
Status
Completed

Conditions

  • Lymphocytic Leukemia, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 18, 2008
Start date
Sep 30, 2008
Status verified
May 2014
Primary completion
Mar 31, 2009
Completion
Mar 31, 2009

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Bone Marrow Response [ Time Frame: Baseline to the end of treatment (up to 24 weeks) ]

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