Combining Selinexor with RCHOP for treating aggressive lymphomas

Prospective, Single-arm, Single-center, Phase II Clinical Study of XPO-1 Inhibitor Selinexor in Combination With RCHOP Regimen in the Treatment of Double Hit/Triple Hit B Cell Lymphoma

This study is testing if adding Selinexor to the standard RCHOP treatment can help people with aggressive lymphomas feel better and improve their chances of survival.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang Cancer Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Hangzhou, Zhenjiang)
• Trial ID: NCT05974085 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Selinexor when used alongside RCHOP as a first-line treatment for patients diagnosed with Double Hit or Triple Hit lymphoma. The study follows a single-arm, single-center design, where participants receive the treatment every 21 days for up to six cycles. The trial includes a screening phase, a treatment phase, and a follow-up period to monitor efficacy and safety outcomes based on established Lugano2014 criteria. Participants will undergo regular imaging evaluations to assess treatment response and overall survival.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed high-grade B-cell lymphoma exhibiting specific genetic rearrangements.

Not a fit: Patients with prior anti-tumor therapies or those with certain types of lymphoma not eligible for this treatment may not benefit.

Why it matters

Potential benefit: If successful, this treatment combination could improve outcomes for patients with aggressive lymphomas that are difficult to treat.

How similar studies have performed: While the combination of Selinexor with RCHOP is a novel approach, similar studies have shown promise in treating aggressive lymphomas.

Eligibility criteria

Inclusion Criteria:

1. Volunteer to participate in clinical studies
2. Age: 18\~75 (inclusive), male and female.
3. Histopathologically confirmed high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 gene rearrangement.
4. No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy.
5. ECOG score is 0-2.
6. there must be at least one evaluable or measurable lesion that meets Lugano2014 criteria.
7. Adequate organ and bone marrow function.
8. Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
9. Serum pregnancy test negative

Exclusion Criteria:

1. Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination. 1) Mixed lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma), or DLBCL transformed from inert non-Hodgkin's lymphoma, or gray zone lymphoma (lymphoma between DLBCL and Hodgkin's lymphoma), or inert lymphoma with MYC, BCL2, BCL6 gene rearrangement.
2. known central nervous system involvement.
3. received prior anti-tumor therapy
4. Is participating in another clinical study or is receiving the first investigational drug less than 4 weeks after the completion of treatment in the previous clinical study
5. Had other malignant tumors in the past 5 years
6. Major surgery was performed within 28 days prior to study initiation
7. Cardiovascular function is unstable
8. Active infection

Where this trial is running

Hangzhou, Zhenjiang

• Zhejiang Cancer Hospital — Hangzhou, Zhenjiang, China (RECRUITING)

Study contacts

• Principal investigator: Cong Li — Zhejiang Cancer Hospital
• Study coordinator: Cong Li

Conditions: Double Hit Lymphoma, Triple Hit Lymphoma, Double/Triple Hit Lymphoma, Selinexor, RCHOP