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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00754650
First received: September 17, 2008
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

This single arm study will evaluate the bone marrow response, safety and tolerability of six months treatment with Avastin monotherapy in patients with chronic lymphocytic leukemia. Patients will receive 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with 6 months of follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Lymphocytic Leukemia, Chronic
Drug: bevacizumab [Avastin]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Avastin in Chronic Lymphocytic Leukemia: Proof of Concept

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Bone marrow response after 6 months of Avastin [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical efficacy (complete response, partial response); molecular complete response; toxicity of treatment; progression-free survival; VEGF levels in serum and bone marrow. [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: September 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
iv 15mg/kg every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female patients, >=18 years of age;
  • B-chronic lymphocytic leukemia not yet requiring treatment;
  • ECOG performance status 0-2;
  • no previous treatment of CLL by chemotherapy, radiotherapy or immunotherapy;
  • life expectancy >6 months.

Exclusion Criteria:

  • CNS involvement by lymphoma or any evidence of spinal cord compression;
  • CT scan based evidence of tumor invading major blood vessels;
  • GI tract involvement by CLL;
  • active viral, bacterial or fungal infection;
  • uncontrolled hypertension, CVA/stroke (<=6 months prior to randomization), myocardial infarction (<=6 months prior to randomization), unstable angina (>=NYHA Grade IV), thrombosis within 6 months before enrollment, NYHA Grade II CHF or serious cardiac arrhythmia requiring ongoing medication.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754650

Locations
Austria
Salzburg, Austria, 5020
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00754650     History of Changes
Other Study ID Numbers: ML21206, 2007-004824-19
Study First Received: September 17, 2008
Last Updated: November 7, 2013
Health Authority: Austria: Federal Agency for Safety in Health Care

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014