Using Selinexor with R-CHOP for TP53-mutated DLBCL patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of selinexor combined with R-CHOP as a first-line treatment for patients with untreated TP53-mutated diffuse large B-cell lymphoma (DLBCL). Participants will undergo 8 cycles of this combination therapy, and those who achieve complete remission will continue with selinexor maintenance therapy. The study aims to determine the complete response rate as the primary endpoint. It is a multi-center, single-arm phase II trial involving multiple locations in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects fully understand and voluntarily participate in this study and sign informed consent.
* Aged ≥18 and ≤80 years, no gender limitation.
* Histologically confirmed DLBCL with TP53 mutations (allowing transformed or concurrent indolent B-cell non-Hodgkin lymphoma)
* No prior systemic anti-lymphoma therapy; prior local radiotherapy alone is permitted.
* There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
* Expected survival ≥ 3 months.
* Adequate function of bone marrow, liver, and kidney.

Exclusion Criteria:

* DLBCL with Hodgkin lymphoma, T-cell lymphoma, or other non-B-cell lymphoma; Richter transformation.
* DLBCL with central nervous system invasion.
* The patients had previously received XPO1 inhibitors.
* The patients have contraindications to any drug in the combined treatment.
* Patients with chronic active hepatitis B or active hepatitis C. If the background hepatitis B surface antigen (HBsAg) and/or hepatitis B core Antibody (HBcAb) or hepatitis C Virus (HCV) antibody are positive, the further determination for Hepatitis B Virus (HBV) DNA (no more than 2500 copies /mL or 500 IU/mL) and HCV RNA (no more than the lower limit of the assay) can be included. The patients with HBsAg and/or HBcAb positive need to receive anti-HBV drugs.
* Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
* Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
* Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
* Mentally ill persons or persons unable to obtain informed consent.
* Any condition deemed unsuitable by the investigator.

Where it's running

• Sun yat-sen university cancer center
  Guangzhou, Guangdong, China Recruiting
• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: QingQing Cai, MD. PhD. — Sun yat-sen university cancer cente
• Study coordinator: QingQing Cai, MD. PhD.
• Email: caiqq@sysucc.org.cn
• Phone: 0086-20-87342823

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.