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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Given PO
Correlative studies
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Best Overall Response Rate (ORR) Including Complete Response (CR) and Partial Response (PR) as Measured by Standard Criteria
An ORR of 20% (4 or more responses among 20 patients) will be taken as a benchmark for success for the primary endpoint of this pilot study. Evaluation of response is per standard NCI Response Criteria Cheson 2014 and assessed by PET-CT; CR = complete metabolic response, PR = decrease by more the 50% in the sum of the product of the perpendicular diameters.
Time frame: Up to 5 years
Time to Treatment Failure
Time frame: From the first treatment administration to the first time to treatment failure, assessed up to 5 years
Progression-free Survival
Kaplan-Meier methodology will be used to estimate event-free curves and corresponding quartiles (including the median).
Time frame: From first study drug administration to the first occurrence of disease progression or death from any cause, assessed up to 5 years
Overall Survival
Time frame: Up to 5 years
Number of Participants With One or More Adverse Events, Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Time frame: Up to 30 days after study treatment completion, an average of 18 weeks.
Disease Control Rate (CR + PR + Stable Disease [SD] > 3 Months)
The count of participants who achieved a CR, PR, or SD for greater than 3 months.
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.