Primary Mediastinal Large B Cell Lymphoma Clinical Trial
Official title:
A Prospective, Single-arm, Multi-center Exploratory Study on the First-line Treatment of Primary Mediastinal Large B-cell Lymphoma ( PMBCL ) With Sintilimab Combined With R-CHOP Regimen
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)
Status | Not yet recruiting |
Enrollment | 32 |
Est. completion date | June 1, 2026 |
Est. primary completion date | June 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | complete remission (CR) | 2years | ||
Primary | overall response rate (ORR) | The proportion of patients with a PR and CR | 2 years | |
Secondary | overall survival (OS) | The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date | 2 years | |
Secondary | progression survival (PFS) | The time from enrollment until tumor progression or death from any cause, whichever occurred first | 2 years | |
Secondary | bio-marker analysis | Correlation between programmed death-ligand 1 expression and efficacy | 2 years |
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