Phase II Study of Bevacizumab (Avastin®) in Myelofibrosis
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Bevacizumab (Avastin®) in Myelofibrosis|
- Reason for Therapy Discontinuation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Patient outcomes for myelofibrosis patients treated on a single agent bevacizumab.
The two subjects who withdrew consent prior to initiation of therapy are included in the "patient refusal" category.
- Number of Cycles [ Time Frame: 2 years ] [ Designated as safety issue: No ]Number of cycles of bevacizumab received. Patients received bevacizumab as a single agent at a dose of 15 mg/kg intravenously on Day 1 of a 21-day cycle.
|Study Start Date:||March 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: bevacizumab (Avastin)
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)
Other Name: Avastin
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667277
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20057|
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|United States, New York|
|Ithaca, New York, United States, 14851|
|Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ronald Hoffman, MD||Myeloproliferative Disorders-Research Consortium|
|Principal Investigator:||Ronald Hoffman, MD||Myeloproliferative Disorders Research Consoritum|