Overview
Tazemetostat for the Treatment of Relapsed/Refractory Follicular Lymphoma
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2024-02-01
2024-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Treating Relapsed/Refractory Follicular Lymphoma with TazemetostatPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hutchison Medipharma Limited
Criteria
Inclusion Criteria:1. Fully aware this study and signed the informed consent form in voluntary manner, and
willing and able to comply with the study procedure;
2. Age ≥18 years;
3. Patients with histologically confirmed R/R FL (Grades 1, 2, 3a)
4. Patients must have one measurable lesion
5. Life expectancy ≥ 12 weeks;
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
7. Adequate bone marrow function, renal function and hepatic function:
8. Currently human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C
virus (HCV) or cytomegalovirus (CMV) is inactive:
9. Female patients of childbearing potential must agree to adopt dual contraceptive
method
Exclusion Criteria:
1. Previous use of Tazemetostat or other EZH2 inhibitors;
2. Patients with invasion of lymphoma to the central nervous system (CNS) or the pia
mater;
3. Previous bone marrow malignancies,
4. Abnormalities associated with MDS and myeloproliferative neoplasms observed by
cytogenetic testing and DNA sequencing;