RecruitingPhase 2NCT05422066

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

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


Sponsor

Li Zhiming

Enrollment

50 participants

Start Date

Jul 26, 2022

Study Type

INTERVENTIONAL

Conditions

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since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called selinexor to the standard chemotherapy regimen (R-CHOP) improves outcomes for people with a specific type of aggressive blood cancer called diffuse large B-cell lymphoma (DLBCL) — particularly the germinal center subtype with high-risk features. **You may be eligible if:** - You are between 18 and 75 years old - You have been newly diagnosed with germinal center B-cell DLBCL (a specific subtype confirmed by biopsy) - You have not previously received chemotherapy or radiation for this cancer (short steroid use is okay) - Your cancer is considered high-risk (prognostic score of 3–5) - Your cancer is visible and measurable on CT or PET scan - You are generally functional and able to care for yourself (ECOG 0–2) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if:** - You have certain rare subtypes of lymphoma (e.g., primary mediastinal, gray zone, or T-cell rich) - Your lymphoma has spread to your brain or spinal cord - You have previously been treated with selinexor or similar drugs - You have an active uncontrolled infection - You have active hepatitis B, C, or HIV not under control - You are pregnant or breastfeeding - You have a life expectancy of less than 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSelinexor

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

DRUGRituximab

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

DRUGCyclophosphamide

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

DRUGDoxorubicin

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

DRUGVincristine

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.

DRUGPrednisone

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

View Full Details on ClinicalTrials.gov

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NCT05422066