A Prospective Study: Sintilimab and R-CHOP in PMBCL Treatment

Launched by SUN YAT-SEN UNIVERSITY · May 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with Primary Mediastinal Large B Cell Lymphoma (PMBCL), a type of cancer that affects the lymphatic system. Researchers want to see how effective and safe the combination of sintilimab, an immunotherapy drug, and the standard chemotherapy regimen known as R-CHOP can be when used as the first treatment for this condition. The trial is not yet recruiting participants, but once it starts, it will enroll adults aged 18 to 75 who have been diagnosed with PMBCL and have not received any prior treatment for this cancer.

To be eligible for the trial, participants should have a good chance of surviving at least six months and meet certain health criteria, such as having a specific blood cell count and normal liver and kidney function. Participants will need to sign a consent form to join the study and should not have any other serious infections or cancers. If you or a family member are considering joining this trial, you can expect to receive careful monitoring and support throughout the treatment process, while helping researchers learn more about how to improve care for PMBCL patients.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Pathological diagnosis of PMBCL , and did not receive any previous treatment for PMBCL ;
• • Predicted survival time ≥ 6 months ;
• • 18-75 years ;
• • IPI score 0-3；
• • ECOG performance status 0-2 ;
• • Clinicians judge that the patient is suitable for the treatment of primary mediastinal large B-cell lymphoma ;
• • After the patient was enrolled in the trial, other drugs that may have therapeutic effects on primary mediastinal large B-cell lymphoma were not acceptable ;
• • WBC ≥ 3 × 109 / L, NE ≥ 1.5 × 109 / L, PLT ≥ 100 × 109 / L ;
• • Serum creatinine ≤ 1.5mg / dL, creatinine clearance rate ≥ 50mL / min ;
• • ALT, AST ≤ 3 × ULN ( normal upper limit ) ; total bilirubin ≤ 2 × ULN ;
• • Sign the informed consent.
• Exclusion Criteria:
• • Other malignant diseases except PMBCL were diagnosed within 5 years；·Participating in other interventional clinical studies, or has received chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
• • Known allergies to test drugs or any excipient component of these products；·Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation has been performed；
• • Women in pregnancy or lactation；
• • Severe infectious diseases, such as HIV infection, untreated active hepatitis B, active hepatitis C；
• • The researchers believe that there are other potential risks that are not suitable for participation in this study.