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 Clinical Trial

Official title:

ML21206 - Bevacizumab in Chronic Lymphocytic Leukemia: A Proof of Concept Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754650
• Other study ID #: ML21206
• Secondary ID: 2007-004824-19
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2008
• Last updated: May 27, 2014
• Start date: September 2008
• Est. completion date: March 2009

Study information

• Verified date: May 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Agency for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphocytic Leukemia, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Best Overall Response (BOR)	The percentage of participants in each BOR category (complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)) is reported. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as = 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as = 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.	Baseline to the end of treatment (up to 24 weeks)	No