A Study of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma
Relapsed/Refractory Lymphoma
About this trial
This is an interventional treatment trial for Relapsed/Refractory Lymphoma
Eligibility Criteria
Criteria: Inclusion Criteria: Willing and able to give informed consent, as documented by signed ICF Age ≥ 18 years Patients with histologically confirmed R/R lymphoma: • Phase IIa (dose escalation study): patients with relapsed or refractory lymphoma who have failed standard treatment and have no standard treatment options • Phase IIb( expansion Study ): Cohort 1 (DLBCL, FL 3b) Histologically confirmed DLBCL, FL 3b (including primary mediastinal B-cell lymphoma) with relapsed/refractory disease Cohort 2 (FL) patients with histologically confirmed R/R FL (Grade 1, 2, 3a) Cohort 3 (MCL): Patients with R/R MCL who had prior therapies Cohort 4 (PTCL): Patients with histologically confirmed R/R PTCL who have failed or cannot tolerate standard therapy Patients must have at least one measurable lesion Life expectancy ≥ 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Adequate bone marrow function, renal function and hepatic function: Currently human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) is inactive Female patients of childbearing potential must agree to use a double contraception method and male patients with partners of childbearing potential must also use an effective double contraception method during the study period and for 3 months after the final dose Exclusion Criteria: Patients who have previously used EZH2 inhibitors and PI3K inhibitors, or previously could not tolerate EZH2 inhibitors or PI3K inhibitors Patients with brain metastases or leptomeningeal invasion Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE 5.0 criteria) and any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS / AML/MPN) Has abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and multiple primary neoplasms (MPN) (e.g. JAK2 V617F) observed in cytogenetic testing and DNA sequencing
Sites / Locations
- Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting
Arms of the Study
Arm 1
Experimental
tazemetostat combined with HMP689 open-label treatment arm
Dose Escalation Phase (Phase IIa): patients with relapsed or refractory lymphoma who have failed standard treatment and have no standard treatment options Dose Expansion Phase (Phase IIb): Cohort 1 (DLBCL, FL 3b): Histologically confirmed DLBCL, FL 3b (including primary mediastinal B-cell lymphoma) with relapsed/refractory disease ; Cohort 2 (FL) patients with histologically confirmed R/R FL (Grade 1, 2, 3a); Cohort 3 (MCL): Patients with R/R MCL who had prior therapies ; Cohort 4 (PTCL): Patients with histologically confirmed R/R PTCL who have failed or cannot tolerate standard therapy