18 and older, any sex, with Ann Arbor Stage I Mantle Cell Lymphoma or Ann Arbor Stage II Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Best Overall Response Rate (ORR) Including Complete Response (CR) and Partial Response (PR) as Measured by Standard CriteriaPrimary· Up to 5 years
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.
Group
Value
95% CI
Treatment (Enzalutamide)
0
Time to Treatment FailureSecondary· From the first treatment administration to the first time to treatment failure, assessed up to 5 years
Group
Value
95% CI
Treatment (Enzalutamide)
14
10 – 35
Progression-free SurvivalSecondary· 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).
Group
Value
95% CI
Treatment (Enzalutamide)
4.1
1.3 – 8.3
Overall SurvivalSecondary· Up to 5 years
Group
Value
95% CI
Treatment (Enzalutamide)
4
Number of Participants With One or More Adverse Events, Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Secondary· Up to 30 days after study treatment completion, an average of 18 weeks.
Group
Value
95% CI
Treatment (Enzalutamide)
8
Disease Control Rate (CR + PR + Stable Disease [SD] > 3 Months)Secondary· Up to 5 years
The count of participants who achieved a CR, PR, or SD for greater than 3 months.
Group
Value
95% CI
Treatment (Enzalutamide)
4
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07287150 — A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
· Phase 2
· recruiting
NCT07226986 — A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI i
· Phase 1, PHASE2
· recruiting
NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum
· Phase 1
· recruiting
NCT07028853 — This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide W
· Phase 3
· recruiting
NCT06922318 — The COSMYC Trial (COmbined Suppression of MYC)
· Phase 2
· recruiting
Other recruiting trials for Ann Arbor Stage I Mantle Cell Lymphoma
Currently open trials in the same condition.
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Other University of Washington trials
Trials by the same sponsor.
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· Phase 2
· not yet recruiting
NCT06422299 — Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Youn
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· not yet recruiting
NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer
· Phase 2
· not yet recruiting
NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Washington
Last refreshed: 10 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02489123.