NCT00142116|CompletedPhase 2ResultsDMC
Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia
Phase II Study of Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia
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Sponsor study identifier
interventional
25
1 country
2
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2004
Actual (reported)Study Completion
February 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
February 2004
Actual (reported)September 1, 2005
Actual (reported)September 2, 2005
Actual (reported)February 2008
Actual (reported)June 2, 2014
Actual (reported)Objective Response Rate
Response determinations were made using modified consensus panel criteria from the Third International Workshop on WM, and response rates were determined on an evaluable basis. A complete response was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. Patients achieving a partial response and a minor response were defined as achieving a more than or equal to 50% and more than or equal to 25% reduction in serum IgM levels, respectively. Patients with stable disease were defined as having less than 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM. Progressive disease was defined as a greater than 25% increase in serum IgM level occurred from the lowest attained response value or progression of clinically significant disease-related symptom(s).
3 years
Time to Progression
Time to disease progression (TTP) was calculated from the start of therapy using the Kaplan-Meier method.
49.1 months
To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity.
3 years
Thalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.
Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Treon SP, Soumerai JD, Branagan AR, Hunter ZR, Patterson CJ, Ioakimidis L, Briccetti FM, Pasmantier M, Zimbler H, Cooper RB, Moore M, Hill J 2nd, Rauch A, Garbo L, Chu L, Chua C, Nantel SH, Lovett DR, Boedeker H, Sonneborn H, Howard J, Musto P, Ciccarelli BT, Hatjiharissi E, Anderson KC. Thalidomide and rituximab in Waldenstrom macroglobulinemia. Blood. 2008 Dec 1;112(12):4452-7. doi: 10.1182/blood-2008-04-150854. Epub 2008 Aug 19.
Steven P. Treon, MD, MA, PhD
Dana-Farber Cancer Institute
25 participants (actual enrollment reported by the registry).
First Submitted
September 1, 2005
First Posted
September 2, 2005
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 2004
Actual (reported)Study Completion
February 2008
Actual (reported)Last Updated
June 2, 2014
Results First Posted
June 2, 2014
Record last verified: 2014-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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