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New treatment option for Primary Mediastinal Diffuse Large B-cell Lymphoma
Official title Sintilimab Plus Rituximab Followed by R-CHOP Regimen in Untreated PMBL
ClinicalTrials.gov ID: NCT06742502
What this study is testing
What is Sintlimab+Rituximab follwed by R-CHOP(Cyclophosphamide, doxorubicin, vincristine, prednisone)?
Sintlimab+Rituximab follwed by R-CHOP(Cyclophosphamide, doxorubicin, vincristine, prednisone) is an investigational medicine, being studied as a potential treatment for primary mediastinal diffuse large b-cell lymphoma.
Also referred to as CD20 antibody plus PD-1 antibody followed by R-CHOP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical study is to evaluate the efficacy and safety of sintilimab combined with rituximab followed by R-CHOP regimen in treatment-naïve patients with primary mediastinal diffuse large B-cell lymphoma. The main questions it aims to answer are: 1.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntary participation in clinical study and fully understand, informed consent and sign informed consent form (ICF);
- Age ≥ 18 years and ≤ 75 years at the time of signing the ICF.
- treatment-naïve, no anti-lymphoma therapy.
- Primary mediastinal DLBCL was confirmed histopathologically at the study site.
- Lugano clinical stage I-IV.
You likely can't join if
- Primary central nervous system lymphoma or secondary central nervous system involvement.
- previous treatment with immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.). 3 History of severe allergic or allergic reactions to humanized or...
See the full eligibility criteria
- Voluntary participation in clinical study and fully understand, informed consent and sign informed consent form (ICF);
- Age ≥ 18 years and ≤ 75 years at the time of signing the ICF.
- treatment-naïve, no anti-lymphoma therapy.
- Primary mediastinal DLBCL was confirmed histopathologically at the study site.
- Lugano clinical stage I-IV.
- International Prognostic Score (IPI) 0-5.
- Available tumor tissue samples obtained by previous or fresh core needle aspiration or resection.
- ECOG score of 0-2.
- Expected survival greater than 12 months.
- Must have at least 1 evaluable or measurable lesion that meets the LYRIC 2016 response evaluation criteria for malignant lymphoma.
- Adequate organ and bone marrow function, no severe hematopoietic dysfunction and heart, lung, liver, kidney, thyroid dysfunction and immunodeficiency.
- Pulse oximetry values \> 92% at rest.
- Women of childbearing potential (WOBCP) must have a negative serum pregnancy test within 7 days before the first dose; WOBCP or men and their WOBCP partners should agree to use effective contraception from signing the...
- Primary central nervous system lymphoma or secondary central nervous system involvement.
- previous treatment with immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.). 3 History of severe allergic or allergic reactions to humanized or murine monoclonal antibodies. 4\. Patients with active autoimmune...
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.