Study of Tazemetostat in Newly Diagnosed Diffuse Large B Cell and Follicular Lymphoma Patients Treated by Chemiotherapy

Exclusion Criteria

• •* for Cohort DLBCL
• •\_\_\_15-Previous treatment for B cell lymphoma, except glucocorticoids (no more than 7 days before inclusion, 1 mg/kg/day max)
• •* for Cohort FOLLICULAR ONLY
• •* 14bis. Prior therapy for lymphoma including radiotherapy except glucocorticoids (no more than 7 days before inclusion, 1 mg/kg/day max)
• •* 17-Pregnant or lactating females
• •* For both Cohorts
• •* 1-Central nervous system or meningeal involvement
• •* 2-Contraindication to any drug contained in the chemotherapy regimen
• •* 3-Prior treatment with tazemetostat or other inhibitor of EZH2
• •* 4-Patients who are undergoing active treatment for another malignancy, exceptions include: A patient who has been disease free for 2 years, or a patient with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible Patients with prior history of myeloid malignancies, including myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia(AML) or prior history of T-LBL/T-ALL are excluded whatever receiving treatment or not and whatever date of diagnosis of these pathologies
• •* 5-Patients taking medications that are known potent CYP3A4 inducers/inhibitors (including St. John's wort)
• •* 6-Patients unwilling to exclude St. John's wort, Seville oranges, grapefruit juice and/or grapefruit from diet
• •* 7-Major surgery within 4 weeks before first dose of study drug (minor procedures including transcutaneous biopsy, central line placement are permitted within 2 weeks of enrollment)
• •* 8-Inability to take oral medication or malabsorption syndrome or any other uncontrolled gastrointestinal condition that would impare ability to take tazemetostat
• •* 9-Significant cardiovascular impairment: congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of first dose of tazemetostat or ventricular arrhythmia
• •* 10-Not applicable
• •* 11-Active uncontrolled infection requiring systemic therapy
• •* 12-Congenital immunodeficiency or known HIV (human immunodeficiency virus infection)
• •* 13-Any other major illness, that in the investigator's judgement, will substantially increase the risk associated with the patient's participation in the study
• •* 14-Patients who have undergone a solid organ transplant
• •* 16-Treatment with any investigational drug or device within 30 days before planned first cycle of chemotherapy
• •* 18-Person deprived of his/her liberty by a judicial or administrative decision
• •* 19-Adult person under legal protection
• •* 20-Person hospitalized without consent
• •* 21-Adult person unabled to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness