Enzalutamide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

Summary

Participation Requirements

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 (pro...

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.

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