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

NCT ID: NCT06412068

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-06-01

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)

Conditions

Primary Mediastinal Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients diagnosed with PMBCL.

Group Type: EXPERIMENTAL

Combined anti-PD-1 and R-CHOP

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Hua Wang

Associate senior doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hua Wang, MD

Role: CONTACT

wagnhua@sysucc.org.cn

+86-15920352412

Other Identifiers

2024-FXY-106

Identifier Type: -

Identifier Source: org_study_id