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Enzalutamide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

Recurrent Mantle Cell Lymphoma Clinical Trial

Official title:
Androgen Receptor Targeting in Mantle Cell Lymphoma: A Pilot Trial of Enzalutamide

Clinical Trial Summary

This pilot clinical trial studies enzalutamide in treating patients with mantle cell lymphoma that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Androgens can cause the growth of cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of androgen made by the body.

Clinical Trial Description

PRIMARY OBJECTIVES: I. Perform a preliminary assessment of the efficacy of single-agent enzalutamide, based on overall response rate, in subjects with relapsed/refractory mantle cell lymphoma (MCL) or previously untreated MCL. SECONDARY OBJECTIVES: I. To evaluate the duration of disease control (progression free survival) in patients with MCL treated with enzalutamide. II. To evaluate the safety profile of enzalutamide in MCL. III. To gain preliminary data on clinical activity and toxicity of this regimen in male versus (vs.) female patients. OUTLINE: Patients receive enzalutamide orally (PO) once daily (QD). Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for up to 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02489123
Study type Interventional
Source University of Washington
Contact
Status Terminated
Phase Phase 2
Start date August 11, 2015
Completion date June 16, 2020
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