Non Hodgkin Lymphoma Clinical Trial

A Study to Assess the Long-term Safety of Tazemetostat

Summary

This rollover study will provide continuing availability to tazemetostat as a single agent to subjects who have completed their participation in an antecedent tazemetostat study (either with monotherapy or combination therapy).

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Full Description

This open-label, multicenter, global study will provide continuing access to tazemetostat therapy for subjects who have completed their participation in a prior tazemetostat study (either with monotherapy or combination therapy)

without unacceptable toxicity, have not had evidence of tumor progression as defined by disease-appropriate standard criteria, and continue to receive clinical benefit from the therapy.

Subjects will receive tazemetostat as dictated in their antecedent study. Visits will be conducted per Standard of Care (SoC) as appropriate in each country and as determined by the Investigator. Subjects will be followed for long-term safety in addition to time to treatment failure (TTF) and overall survival (OS).

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Eligibility Criteria

Inclusion Criteria:

Subjects must meet ALL criteria to be eligible for enrollment in this study.
Has demonstrated and continues to demonstrate clinical benefit from treatment with tazemetostat.
Is currently receiving tazemetostat as either monotherapy or in combination with other approved drug(s) or investigational agent(s) on an Epizyme-sponsored clinical trial or any other clinical trial being conducted with tazemetostat that is not sponsored by Epizyme (including but not limited to, investigator-initiated trials). For subjects on combination therapy, treatment with other therapeutic(s) must have been completed in the antecedent study or will be provided by a source other than Epizyme if combination therapeutics are continued in this study until disease progression, treatment toxicity, subject preference or death, up to approximately 7 years.
Has voluntarily provided signed written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
Has a life expectancy of ≥3 months.
Has adequate hematologic, (bone marrow [BM] and coagulation factors), renal, and hepatic function. Subject must remain eligible for continued treatment with tazemetostat according to the eligibility and treatment criteria from the antecedent study

Exclusion Criteria:

Subjects meeting ANY of the following criteria must NOT be enrolled in this study:

Has had an interruption of tazemetostat dosing of >14 days from the antecedent clinical study to starting the rollover study unless approved by the Medical Monitor.

Has another malignancy other than the one for which they are receiving tazemetostat.

• Exception: Subject who has been disease-free of a prior malignancy for 5 years or subject with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible.

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT02875548

Recruitment Status:

Enrolling by invitation

Sponsor:

Epizyme, Inc.

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There are 20 Locations for this study

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University of Arizona Cancer Center
Tucson Arizona, 85724, United States
Moffitt
Tampa Florida, 33612, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Columbia University Medical Center
New York New York, 10019, United States
Monash Medical Centre- Monash Campus
Clayton , 3168, Australia
Geelong Hospital
Geelong , , Australia
Peter MacCallum Cancer Institute
Melbourne , 3002, Australia
University Hospital (UZ) Leuven
Leuven , 3000, Belgium
Institut Bergonie
Bordeaux Cedex , 33076, France
CHU de Caen - Hôpital Côte de Nacre
Caen , 14033, France
CHRU de Lile- Hopital Claude Huriez
Lille Cedex , 59037, France
Hôpital Saint Louis - AP-HP
Paris , 75010, France
Centre Hospitalier Lyon Sud
Pierre-Bénite , 69310, France
CHU Rennes- Hopital Pontchaillou
Rennes Cedex , 35033, France
Centre Henri Becquerel
Rouen , 76038, France
Gustave Roussay
Villejuif , 94805, France
Pratia MCM Krakow
Kraków , 30-51, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Endokrynologii Onkologicznej i Medycyny Nuklearnej
Warszawa , , Poland
S.P. Grigoreva Institute of Medical Radiology and Oncology of NAMS of Ukraine"
Kharkiv , 61024, Ukraine
Beatson, West of Scotland Cancer Centre
Glasgow , , United Kingdom
Oncology and Haematology Clinical Trials Unit
Leicester , LEI 5, United Kingdom
Clatterbridge Cancer Centre
Liverpool , L7 8X, United Kingdom
Hammersmith Hospital
London , W12 0, United Kingdom
The Christie NHS Foundation Trust
Manchester , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT02875548

Recruitment Status:

Enrolling by invitation

Sponsor:


Epizyme, Inc.

How clear is this clinincal trial information?

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