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RECRUITING
NCT05422066
PHASE2

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

Sponsor: Li Zhiming

View on ClinicalTrials.gov

Summary

This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study. And the objective is to Evaluate the safety and efficacy of XR-CHOP in High-Risk (IPI 3-5) GCB-subtype DLBCL.The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.

Official title: Frontline Selinexor(ATG-010) Plus R-CHOP Therapy for High-risk GCB-subtype Diffuse Large B-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2022-07-26

Completion Date

2025-12-31

Last Updated

2024-06-17

Healthy Volunteers

No

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.

Locations (6)

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

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China