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Sponsored by: |
Myeloproliferative Disorders-Research Consortium |
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Information provided by: | Myeloproliferative Disorders-Research Consortium |
ClinicalTrials.gov Identifier: | NCT00667277 |
Myelofibrosis is the gradual replacement of bone marrow (place where most new blood cells are produced) by fibrous tissue which reduces the body's ability to produce new blood cells and results in the development of chronic anemia (low red blood cell count). One of the main distinctions of myelofibrosis is "extramedullary hematopoiesis", the migration or traveling of the blood-forming cells out of the bones to other parts of the body, such as the liver or spleen, resulting in an enlarged spleen and liver.
There is not a standard treatment for myelofibrosis, therefore there is no medication that is specifically used in the treatment of myelofibrosis.
Bevacizumab (Avastin®) targets and stops a growth factor in the body that helps produce the type of fibrous tissue that is gradually replacing the bone marrow in the bones.
The purpose of this study is to find out how safe and effective bevacizumab is in treating myelofibrosis. The investigators also wish to find out important biologic characteristics or features of myelofibrosis (how it works and operates) during the time of study participation through an additional correlative biomarker study (MPD-RC #107). The purpose of the biomarker study is to understand the causes of MPD and to develop improved methods for the diagnosis and treatment of these diseases, while the main study is trying to find out how well bevacizumab will work in treating the disease.
Condition | Intervention | Phase |
---|---|---|
Myelofibrosis |
Drug: bevacizumab (Avastin) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Bevacizumab (Avastin®) in Myelofibrosis |
Estimated Enrollment: | 34 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Use of bevacizumab (Avastin) in the treatment of myelofibrosis.
|
Drug: bevacizumab (Avastin)
15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Proteinuria at screening as demonstrated by either
Contact: Ronald S Hoffman, MD | (212) 241-2297 | ronald.hoffman@mssm.edu |
Contact: Srdan S Verstovsek, MD, PhD | (713) 745-3429 | sverstov@mdanderson.org |
United States, District of Columbia | |
Georgetown University | Recruiting |
Washington, District of Columbia, United States, 20057 | |
Principal Investigator: Craig Kessler, MD | |
United States, Illinois | |
University of Illinois at Chicago | Recruiting |
Chicago, Illinois, United States, 60612 | |
Principal Investigator: Damiano Rondelli, MD | |
United States, New York | |
Mount Sinai Medical Center | Recruiting |
New York, New York, United States, 10029 | |
Principal Investigator: Ronald Hoffman, MD | |
Weill Cornell | Recruiting |
Ithaca, New York, United States, 14851 | |
Principal Investigator: Richard Silver, MD | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Srdan Verstovsek | |
United States, Utah | |
University of Utah | Recruiting |
Salt Lake City, Utah, United States, 84102 | |
Principal Investigator: Joseph Prachal, MD |
Study Chair: | Ronald Hoffman, MD | Myeloproliferative Disorders-Research Consortium |
Responsible Party: | MyeloproliferativeDRC ( Ronald Hoffman, MD - Study Chair ) |
Study ID Numbers: | MPD-RC 103, P01 CA 108671-01A2 |
Study First Received: | April 24, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00667277 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Myelofibrosis Idiopathic Bevacizumab Avastin |
bone marrow fibrosis bone marrow angiogenesis JAK2 |
Myeloid Metaplasia Lymphatic Diseases Myelofibrosis Hematologic Diseases Fibrosis |
Metaplasia Myeloproliferative Disorders Bevacizumab Bone Marrow Diseases Angiogenesis Inhibitors |
Myelofibrosis Antineoplastic Agents Hematologic Diseases Growth Substances Physiological Effects of Drugs Myeloproliferative Disorders Bevacizumab Angiogenesis Inhibitors |
Pharmacologic Actions Myeloid Metaplasia Lymphatic Diseases Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Bone Marrow Diseases Splenic Diseases |