Trials / Terminated
TerminatedNCT03269552
Carfilzomib With or Without Rituximab in the Treatment of Waldenstrom Macroglobulinemia or Marginal Zone Lymphoma
A Response-Adapted Clinical Trial of Weekly Carfilzomib With or Without Rituximab for Waldenström's Macroglobulinemia and Marginal Zone Lymphoma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well carfilzomib with or without rituximab work in treating patients with Waldenstrom macroglobulinemia or marginal zone lymphoma that is previously untreated, has come back, or does not respond to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as rituximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving carfilzomib alone when disease is responding or with rituximab when disease is not responding may work better in treating patients with Waldenstrom macroglobulinemia or marginal zone lymphoma.
Detailed description
PRIMARY OBJECTIVES: 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). SECONDARY OBJECTIVES: 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. OUTLINE: 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.
Conditions
- Marginal Zone Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Waldenstrom Macroglobulinemia
- Refractory Marginal Zone Lymphoma
- Refractory Waldenstrom Macroglobulinemia
- Waldenstrom Macroglobulinemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Carfilzomib | Given IV |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| BIOLOGICAL | Rituximab | Given IV |
Timeline
- Start date
- 2017-12-18
- Primary completion
- 2018-12-28
- Completion
- 2018-12-28
- First posted
- 2017-08-31
- Last updated
- 2020-01-18
- Results posted
- 2020-01-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03269552. Inclusion in this directory is not an endorsement.