TerminatedPhase 2

Enzalutamide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

Stopped: Accrual goal not met

United States8 participantsStarted 2015-08-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have histologically confirmed relapsed/refractory or previously untreated mantle cell lymphoma (any stage) * Patients with untreated MCL should be asymptomatic or minimally symptomatic from their MCL and without aggressive clinicopathological features that would otherwise warrant immediate intensive therapy; these will generally be patients who qualify for an initial period of "watch and wait" per clinical discretion * Patients must have metabolically active (positron emission tomography \[PET\] scan positive) measurable disease (defined as lesions greater than 1.5 cm long axis that can be accurately measured in two dimensions by computed tomography \[CT\]) * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Absolute neutrophil count (ANC) \>= 1000/mm\^3 or \>= 750/mm\^3 in the setting of marrow involvement by disease (independent of growth factor or transfusion support) * Platelets \>= 50,000/mm\^3 or \>= 30,000/mm\^3 in the setting of marrow involvement by disease or splenomegaly due to disease (independent of growth factor or transfusion support) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN) * Total bilirubin =\< 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin * Creatinine clearance (CrCl) \>= 30 mL/min (as calculated by Cockcroft-Gault equation) * All patients must be informed of the investigationa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Best Overall Response Rate (ORR) Including Complete Response (CR) and Partial Response (PR) as Measured by Standard Criteria

Timeframe: Up to 5 years

Trial details

NCT IDNCT02489123

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-16

Results submitted2021-06-11

View on ClinicalTrials.gov More Ann Arbor Stage I Mantle Cell Lymphoma trials