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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412068
• Other study ID #: 2024-FXY-106
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2024
• Source: Sun Yat-sen University
• Contact: Hua Wang, MD
• Phone: +86-15920352412
• Email: wagnhua[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Primary Mediastinal Large B Cell Lymphoma

Intervention

Drug:
• Combined anti-PD-1 and R-CHOP
Sintilimab,200mg, d1, intravenous drip; Rituximab,375mg/?, d1,intravenous drip; Cyclophosphamide,750mg/?,d2,intravenous drip; Doxorubicin,50mg/? (or Liposome doxorubicin ,40 mg/?),d2,intravenous drip; Vincristine,1.4mg/?, d2(Maximum dose 2mg),intravenous drip; Prednisone, 60mg/ m2 , d1-d5,oral administration.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

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