Phase
Condition
Non-hodgkin's Lymphoma
Lymphoma
Treatment
HH2853 Tablets
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- main inclusion:
Tumor types and prior antitumor therapy: Phase Ib:Dose Escalation: All enrolledpatients must have histologically confirmed diagnosis NHL who have received atleast one line of prior systematic treatment (and ≤ 5 lines) and relapses orrefractory. Phase Ib dose expansion part: All enrolled patients must havehistologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL,ALK + ALCL, ALK-ALCL, NKTCL, enteropathy associated T-cell lymphoma (EATL),monomorphic epitheliotropic internal T-cell lymphoma (MEITL), HepatosplenicT-cell lymphoma (HSTCL), follicular T-cell lymphoma (FTCL), Nodal peripheralT-cell lymphoma with TFH phenotype (Nodal PTCL-TFH) and other invasive T-cellsources NHL at the investigator and sponsor's discretion (except highlyinvasive). All enrolled patients had relapsed or refractory diseases afterreceiving 1-line systematic treatment (≤ 3 lines). Phase II: All enrolledpatients must have histologically confirmed diagnosis of PTCL, includingsubtypes: PTCL-NOS, AITL, ALK+ALCL, ALK-ALCL, NKTCL, EATL, MEITL, HSTCL, FTCL,Nodal PTCL-TFH et al. Patients must have histologically confirmed diagnosis ofR/R PTCL who have received at least one line of prior systematic combinationchemotherapy and at least one new drug therapy (prior antitumor treatment lines ≤4 lines) : relapse and/or refractory.
Availability of qualified tissue samples by patient for pathological diagnosisby the central laboratory.
The Eastern cooperative oncology group (ECOG) score 0-1.
Life expectancy ≥ 3 months before starting HH2853 treatment.
Sufficient bone marrow, liver and renal functions.
Exclusion
Exclusion Criteria:
- main criteria:
Previous treatment with EZH2 or EZH1/2 inhibitors.
Central nervous system invasion.
Any previous history of bone marrow malignancy, including myelodysplasticsyndrome (MDS).
Received medications that are known potent CYP3A4 inducers/inhibitors within 1week prior to first dose.
Study Design
Study Description
Connect with a study center
Sichuan Cancer Hospital
Chengdu, Chengdu
ChinaSite Not Available
Sichuan Cancer Hospital
Chengdu 1815286, Chengdu
ChinaActive - Recruiting

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