A Prospective Study: Sintilimab and R-CHOP in PMBCL Treatment
Phase 2
Not yet recruiting
- Conditions
- Primary Mediastinal Large B Cell Lymphoma
- Interventions
- Drug: Combined anti-PD-1 and R-CHOP
- Registration Number
- NCT06412068
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
The purpose of this multi-center, single arm, phase Ⅱ 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 32
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients diagnosed with PMBCL. Combined anti-PD-1 and R-CHOP -
- Primary Outcome Measures
Name Time Method overall response rate (ORR) 2 years The proportion of patients with a PR and CR
complete remission (CR) 2years
- Secondary Outcome Measures
Name Time Method bio-marker analysis 2 years Correlation between programmed death-ligand 1 expression and efficacy
overall survival (OS) 2 years The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date
progression survival (PFS) 2 years The time from enrollment until tumor progression or death from any cause, whichever occurred first