Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142116
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2005-09-01
Brief Title:
Thalidomide and Rituximab in Waldenstroms Macroglobulinemia
Sponsor:
Steven P Treon MD PhD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Study of Thalidomide and Rituximab in Waldenstroms Macroglobulinemia
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Patients will receive thalidomide200mg 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 immunoglobulin M IgM levels bone marrow involvement tumor cells andor 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
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 immunoglobulin M IgM levels bone marrow involvement tumor cells andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None