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Trial Title:
A Prospective Study: Sintilimab and R-CHOP in PMBCL Treatment
NCT ID:
NCT06412068
Condition:
Primary Mediastinal Large B Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Conditions: Keywords:
primary mediastinal large B cell lymphoma
sintilimab
R-CHOP
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Combined anti-PD-1 and R-CHOP
Description:
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.
Arm group label:
Patients diagnosed with PMBCL.
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)
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 1, 2024
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06412068
