Long-Term Safety of Tazemetostat for Lymphoma
(TRuST Trial)

Recruiting in Palo Alto (17 mi)

+36 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Epizyme, Inc.

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will provide continuing availability to tazemetostat for people that have previously completed participation in a tazemetostat study, either with monotherapy (single drug treatment) or combination therapy. The aim of the study will be to assess the long-term safety of tezemetostat.

Research Team

Ipsen Medical Director

Principal Investigator

Ipsen

Eligibility Criteria

This trial is for people who have seen benefits from tazemetostat in previous studies, can follow the study rules, and are expected to live at least 3 more months. They should be currently taking tazemetostat alone or with other drugs and have good blood, kidney, and liver function. People can't join if they've stopped tazemetostat for over 2 weeks without approval, have another cancer (with some exceptions), or severe blood problems.

Inclusion Criteria

Has a life expectancy of ≥3 months.

Has voluntarily provided signed written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.

I am benefiting from my current tazemetostat treatment.

See 4 more

Exclusion Criteria

I have another cancer besides the one being treated, but it's either been 5 years since I was disease-free, or it was a non-melanoma skin cancer or in situ carcinoma that was completely removed or treated.

I stopped taking tazemetostat for more than 14 days before joining this study.

I have a history of T-cell lymphoblastic lymphoma/leukemia.

See 1 more

Treatment Details

Interventions

Tazemetostat (Epigenetic Modulator)

Trial OverviewThe focus of this study is on the long-term safety of a drug called tazemetostat. Participants are those who previously responded well to this medication either by itself or combined with other treatments in past research trials.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Open-label TazemetostatExperimental Treatment1 Intervention

Participants will continue to receive the same tazemetostat dose and schedule as specified in their antecedent tazemetostat protocol. For participants on combination therapy, the other therapeutic(s) must have been completed in the antecedent study or be provided by a source other than Epizyme if combination treatment is continued in this clinical rollover study.