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

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06412068

Enrollment

Registered

2024-05-14

Start date

2024-06-01

Completion date

2026-06-01

Last updated

2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Mediastinal Large B Cell Lymphoma

Keywords

primary mediastinal large B cell lymphoma, sintilimab, R-CHOP

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)

Interventions

DRUGCombined 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
complete remission (CR)	2years	—
overall response rate (ORR)	2 years	The proportion of patients with a PR and CR

Secondary

Measure	Time frame	Description
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
bio-marker analysis	2 years	Correlation between programmed death-ligand 1 expression and efficacy

Contacts

Primary ContactHua Wang, MD

wagnhua@sysucc.org.cn+86-15920352412

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026