Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 26, 2022

Primary Completion Date

July 30, 2025

Study Completion Date

December 31, 2025

Conditions
DLBCL Germinal Center B-Cell Type
Interventions
DRUG

Selinexor

Selinexor (ATG-010# is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs. Selinexor 60mg on day 1,8,15 for 21 days cycles

DRUG

Rituximab

Induction Chemotherapy: 375mg/sqm, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

DRUG

Cyclophosphamide

Induction Chemotherapy: 750mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

DRUG

Doxorubicin

Induction Chemotherapy: 70mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

DRUG

Vincristine

Induction Chemotherapy: 1.4mg/m2 (Max: 2mg), Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

DRUG

Prednisone

Induction Chemotherapy: 100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

Trial Locations (6)

315000

NOT_YET_RECRUITING

The Affiliated People's Hospital of Ningbo University, Ningbo

410013

NOT_YET_RECRUITING

Hunan Cancer Hospital, Changsha

430022

NOT_YET_RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

430079

NOT_YET_RECRUITING

Hubei Cancer Hospital, Wuhan

450008

NOT_YET_RECRUITING

Henan Cancer Hospital, Zhengzhou

510060

RECRUITING

Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou

All Listed Sponsors
collaborator

Antengene Corporation

INDUSTRY

lead

Li Zhiming

OTHER