Carfilzomib With or Without Rituximab in the Treatment of Waldenstrom Macroglobulinemia or Marginal Zone Lymphoma
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|ClinicalTrials.gov Identifier: NCT03269552|
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Marginal Zone Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Waldenstrom Macroglobulinemia Refractory Marginal Zone Lymphoma Refractory Waldenstrom Macroglobulinemia Waldenstrom Macroglobulinemia||Drug: Carfilzomib Other: Laboratory Biomarker Analysis Biological: Rituximab||Phase 2|
I. Determine the overall response rate of single-agent weekly carfilzomib (CFZ), measured after 2 cycles of therapy, in Waldenstrom's macroglobulinemia (WM) and marginal zone lymphoma (MZL).
I. Assess safety and tolerability of single agent, weekly CFZ in patients with WM and MZL, and determine the tolerability of weekly CFZ+rituximab for applicable patients.
II. Estimate the time to best response, response duration, and survival with weekly CFZ for WM and MZL.
III. Evaluate the overall response rate associated with weekly CFZ in a subset of patients with rituximab refractory WM or MZL.
Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib, receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Response-Adapted Clinical Trial of Weekly Carfilzomib With or Without Rituximab for Waldenström's Macroglobulinemia and Marginal Zone Lymphoma|
|Actual Study Start Date :||December 18, 2017|
|Estimated Primary Completion Date :||September 15, 2020|
|Estimated Study Completion Date :||September 15, 2020|
Experimental: Treatment (carfilzomib, rituximab)
Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib, receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Overall response rate [ Time Frame: Up to 1 year ]Descriptive statistics will be used for baseline characteristics, and responses to treatment.
- Survival outcomes [ Time Frame: Up to 1 year ]Estimated using Kaplan-Meier analysis.
- Time to best response [ Time Frame: Up to 1 year ]Estimated using Kaplan-Meier analysis.
- Time to progression [ Time Frame: Up to 1 year ]Estimated using Kaplan-Meier analysis.
- Change in CD19 and CD20 expression following carfilzomib therapy assessed in peripheral blood samples [ Time Frame: Up to 1 year ]Changes in mean fluorescence intensity pre- and post-carfilzomib of both CD20 and CD19 will be assessed compared using paired T testing. Peripheral blood samples from each patient before therapy and again after 2 cycles of carfilzomib, will be submitted for quantitative evaluation of CD19 and CD20 surface expression (measuring mean fluorescence intensity).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269552
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Stephen D. Smith 206-606-6546 firstname.lastname@example.org|
|Principal Investigator: Stephen D. Smith|
|Principal Investigator:||Stephen Smith||Fred Hutch/University of Washington Cancer Consortium|