Enzalutamide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT02489123|
Recruitment Status : Recruiting
First Posted : July 2, 2015
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ann Arbor Stage I Mantle Cell Lymphoma Ann Arbor Stage II Mantle Cell Lymphoma Ann Arbor Stage III Mantle Cell Lymphoma Ann Arbor Stage IV Mantle Cell Lymphoma Recurrent Mantle Cell Lymphoma Refractory Mantle Cell Lymphoma||Drug: Enzalutamide Other: Laboratory Biomarker Analysis||Not Applicable|
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.
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.
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Androgen Receptor Targeting in Mantle Cell Lymphoma: A Pilot Trial of Enzalutamide|
|Actual Study Start Date :||August 11, 2015|
|Estimated Primary Completion Date :||July 1, 2023|
Experimental: Treatment (enzalutamide)
Patients receive enzalutamide PO 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.
Other: Laboratory Biomarker Analysis
- Best overall response rate (ORR) including complete response (CR) and partial response (PR) as measured by standard criteria [ Time Frame: Up to 5 years ]An ORR of 20% will be taken as a benchmark for success for the primary endpoint of this pilot study.
- 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 [ Time Frame: From first study drug administration to the first occurrence of disease progression or death from any cause, assessed up to 5 years ]Kaplan-Meier methodology will be used to estimate event-free curves and corresponding quartiles (including the median).
- Overall survival [ Time Frame: Up to 5 years ]
- Incidence of 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 ]
- Disease control rate (CR + PR + stable disease [SD] > 3 months) [ Time Frame: Up to 5 years ]
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): NCT02489123
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Ajay K. Gopal 206-606-2037 email@example.com|
|Principal Investigator: Ajay K. Gopal|
|Principal Investigator:||Ajay Gopal||Fred Hutch/University of Washington Cancer Consortium|