XPO-1 in Combination With RCHOP for DH/TH Lymphoma

Launched by ZHEJIANG CANCER HOSPITAL · Aug 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with Double Hit Lymphoma (DH Lymphoma) or Triple Hit Lymphoma (TH Lymphoma). Researchers want to see if a medication called Selinexor, when combined with the standard chemotherapy regimen RCHOP, can help improve treatment outcomes for these types of aggressive lymphomas. The trial is currently looking for participants aged 18 to 75 who have a confirmed diagnosis of high-grade B-cell lymphoma with specific genetic changes and who haven't received any previous cancer treatments.

If you or a loved one are interested in participating, you'll need to be in good overall health and have certain measurable signs of your lymphoma. Participants can expect close monitoring throughout the study to ensure their safety and to assess how well the treatment is working. It's important to know that this trial excludes individuals with certain heart conditions, previous cancer treatments, or other serious health issues. Overall, this study aims to provide new insights into effective first-line treatments for these challenging types of lymphoma.

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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