Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia
Recruitment status was Active, not recruiting
The purpose of this study is to determine the percentage of people who can attain remission and the length of time such responses to therapy are sustained, as well as the side effects that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia|
- To define objective response to time to treatment failure, and toxicity for combined thalidomide and rituximab therapy in Waldenstrom's macroglobulinemia patients. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To identify the mechanism(s) of action for combined thalidomide and rituximab activity. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2003|
|Estimated Study Completion Date:||February 2008|
|Primary Completion Date:||February 2004 (Final data collection date for primary outcome measure)|
- Patients will receive thalidomide(200mg) orally once daily for two weeks. If after two weeks of thalidomide, the patient is doing well the dose of thalidomide will increase (400mg) and they will remain on it for up to 50 additional weeks. The length of time a patient is on thalidomide will depend upon how they are responding to therapy.
- During the second week of the study patients will also begin receiving rituximab intravenously once weekly for 4 weeks, which may then be repeated 8 weeks later depending upon the response.
- A determination of how the patient is responding will be made based on testing conducted at 12 weeks. This testing includes blood tests and possibly a bone marrow biopsy. If it is determined that the disease is not progressing, patients will begin a second phase of treatment which includes 4 additional weekly infusions of rituximab and the continuation of oral thalidomide.
- If it is determined at the 12-week evaluation, or at any time thereafter, that the disease has progressed (by studying serum IgM levels, bone marrow involvement, tumor cells, and/or development of new signs and symptoms) then the patient will be removed from the study.
- Periodic examinations and tests will be done to determine how the patient is doing, what response and side effects (if any) the patient may be having from the study drugs. If patient is responding to therapy then they will remain on this study and followed for a period of two years.
- Bone marrow biopsies and aspirations will be obtained at 3-6 month intervals extending for 2 years following the last treatment.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Steven P. Treon, MD, MA, PhD||Dana-Farber Cancer Institute|