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

Phase 1 & 2

Waitlist Available

Research Sponsored by Epizyme, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has demonstrated and continues to demonstrate clinical benefit from treatment with tazemetostat

Be older than 18 years old

Must not have

Has a prior history of T-LBL/T-ALL.

Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE v5 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until end of study an average of 7 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will provide tazemetostat to subjects who have completed a previous trial with the same drug.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While not specified here, common side effects of tazemetostat may include fatigue, nausea, loss of appetite, constipation or diarrhea. More serious risks could involve changes in blood cell counts leading to infections or bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am responding well to my tazemetostat treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have severe blood cell count issues or a history of blood cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until end of study an average of 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until end of study an average of 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and until end of study an average of 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of Study Drug Exposure

Percentage of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Event (TEAEs)

Secondary study objectives

The overall survival (OS)

Other study objectives

The time to treatment failure (TTF) in subjects receiving tazemetostat

Side effects data

From 2021 Phase 2 trial • 20 Patients • NCT03456726

53%

Dysgeusia

41%

Nasopharyngitis

29%

Blood creatine phosphokinase increased

29%

Upper respiratory tract infection

29%

Lymphopenia

29%

Constipation

29%

Stomatitis

24%

Rash

18%

Weight decreased

18%

Blood creatinine increased

18%

Thrombocytopenia

18%

Neutropenia

18%

Nausea

12%

Influenza

12%

Amylase increased

12%

Herpes simplex

12%

Malaise

12%

Pneumonia

12%

Urinary tract infection

12%

Hypertriglyceridaemia

12%

Anaemia

12%

Hypophosphataemia

12%

Alopecia

12%

Eczema

Upper respiratory tract inflammation

Traumatic fracture

Aspartate aminotransferase increased

Blood zinc decreased

Haematuria

Electrocardiogram QT prolonged

Skin exfoliation

Oedema peripheral

Hypoalbuminaemia

Fatigue

Gastroenteritis

Impetigo

Blood pressure decreased

Visual field defect

Osteonecrosis of jaw

Hypogammaglobulinaemia

Rash maculo-papular

Phlebitis

Nail disorder

Pyrexia

Myalgia

Gamma-glutamyltransferase increased

Insomnia

Traumatic intracranial haemorrhage

Hypertonic bladder

Musculoskeletal chest pain

Gastric cancer

Non-small cell lung cancer

Haematochezia

Tooth disorder

Bronchitis

Abdominal pain

Large intestine polyp

Pneumocystis jirovecii pneumonia

Alanine aminotransferase increased

Immature granulocyte count increased

Cataract

Mechanical ileus

Atypical pneumonia

Periodontitis

Pneumonia aspiration

Leukopenia

Pericardial effusion

Conjunctival haemorrhage

Visual impairment

Epigastric discomfort

Oral herpes

Paronychia

Fall

Postoperative delirium

Procedural pain

Skin laceration

Tooth fracture

Hyperglycaemia

Hyperkalaemia

Hyperuricaemia

Pain in extremity

Tendon disorder

Myelodysplastic syndrome

Muscle spasticity

Peripheral motor neuropathy

Sciatica

Syncope

Asthma

Dysphonia

Erythema multiforme

Keloid scar

100%

80%

60%

40%

20%

Study treatment Arm

Participants With Follicular Lymphoma

Participants With Diffuse Large B-cell Lymphoma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tazemetostat

2016

Completed Phase 2

~1050

0 / 3Eligibility criteria met