Non Hodgkin Lymphoma Clinical Trial
A Study to Assess the Long-term Safety of Tazemetostat
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).
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).
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 â‰¥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
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.
â€¢ 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 â‰¥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.
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There are 20 Locations for this study
Tucson Arizona, 85724, United States
Tampa Florida, 33612, United States
Ann Arbor Michigan, 48109, United States
New York New York, 10019, United States
Clayton , 3168, Australia
Geelong , , Australia
Melbourne , 3002, Australia
Leuven , 3000, Belgium
Bordeaux Cedex , 33076, France
Caen , 14033, France
Lille Cedex , 59037, France
Paris , 75010, France
Pierre-BÃ©nite , 69310, France
Rennes Cedex , 35033, France
Rouen , 76038, France
Villejuif , 94805, France
KrakÃ³w , 30-51, Poland
Warszawa , , Poland
Kharkiv , 61024, Ukraine
Glasgow , , United Kingdom
Leicester , LEI 5, United Kingdom
Liverpool , L7 8X, United Kingdom
London , W12 0, United Kingdom
Manchester , , United Kingdom
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