Trials / Terminated
TerminatedNCT02489123
Enzalutamide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
Androgen Receptor Targeting in Mantle Cell Lymphoma: A Pilot Trial of Enzalutamide
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enzalutamide | Given PO |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
Timeline
- Start date
- 2015-08-11
- Primary completion
- 2020-06-16
- Completion
- 2020-06-16
- First posted
- 2015-07-02
- Last updated
- 2021-08-10
- Results posted
- 2021-08-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02489123. Inclusion in this directory is not an endorsement.