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

NCT06412068 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2024-FXY-106
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• complete remission (CR)

  2years

• overall response rate (ORR)

  The proportion of patients with a PR and CR

  2 years

Secondary Outcomes (3)

• overall survival (OS)

  2 years

• progression survival (PFS)

  2 years

• bio-marker analysis

  2 years

Study Arms (1)

Patients diagnosed with PMBCL.

EXPERIMENTAL

Drug: Combined anti-PD-1 and R-CHOP

Interventions

Combined anti-PD-1 and R-CHOP 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.

Patients diagnosed with PMBCL.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological diagnosis of PMBCL , and did not receive any previous treatment for PMBCL ;
• Predicted survival time ≥ 6 months ;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Central Study Contacts

Hua Wang, MD

CONTACT

+86-15920352412; wagnhua@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate senior doctor

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 14, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05