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:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00754650
First received: September 17, 2008
Last updated: January 17, 2012
Last verified: January 2012
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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: | December 2010 |
| 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 More Information
No publications provided
| Responsible Party: | Disclosures Group, 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: | January 17, 2012 |
| 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 June 18, 2013