A Prospective Study: Sintilimab and R-CHOP in PMBCL Treatment (NCT06412068) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Prospective Study: Sintilimab and R-CHOP in PMBCL Treatment
32 participantsStarted 2024-06-01
Plain-language summary
The purpose of this multi-center, single arm, phase â…¡ clinical trail is to evaluate the efficacy and toxicity of sintilimab combined with R-CHOP regimen as first-line treatment for primary mediastinal large B-cell Lymphoma (PMBCL)
Who can participate
Age range18 Years – 75 Years
SexALL
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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 0-3ï¼›
* 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 lactationï¼›
* Severe infectious diseases, such as HIV infection, untreated active hepatitis B, active hepatitis Cï¼›
* The researchers believe that there are other potential risks that are not suitable for participation in this study.