The Efficacy and Safety of the RCMOP Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission.

Study Overview
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Brief Summary
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A clinical study was conducted to evaluate the efficacy and safety of the RCMOP regimen sequential therapy as a first-line treatment for patients with intermediate-to-high risk diffuse large B-cell lymphoma who had incomplete remission.

Official Title
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A Clinical Study Was Conducted to Evaluate the Efficacy and Safety of the RCMOP Regimen Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission.

Conditions
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Diffuse Large B-cell Lymphoma

Intervention / Treatment
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* Drug: Mitoxantrone hydrochloride liposome injection
* Drug: RiTUXimab Injection
* Drug: Cyclophosphamid
* Drug: Vincristine
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects fully understand and voluntarily participate in this study and sign informed consent Age≥18 years old International Prognostic Index (IPI)>2 Expected survival ≥ 3 months DLBCL initially diagnosed by histopathology meets the following subtypes according to the 2016 WHO classification: (1) Germinal center B-cell-like (GCB) subtype; (2) Non-germinal center B-cell-like (non-GCB) subtype Patients who were evaluated as incomplete remission after 2 cycles of RCHOP/RCDOP for initial treatment At least 1 evaluable or measurable lesion meeting Lugano 2014 criteria: Nodal lesion: Greatest transverse diameter>1.5cm; Extra-nodal lesion: Greatest transverse diameter>1.0cm ECOG Performance Status: 0-1 Bone marrow function: Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥75×10^9/L, Hemoglobin ≥ 80g/L (Patients with bone marrow involvement were judged by the investigator to enter the group) Liver and kidney function: serum creatinine ≤ 1.5×ULN (upper limit of normal); AST and ALT ≤ 2.5×ULN (≤ 5×ULN for subjects with liver metastases); total bilirubin ≤ 1.5×ULN (≤ 3×ULN for subjects with liver metastases). Exclusion Criteria: Hypersensitivity to any study drug or its components Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.) Heart function and disease meet one of the following conditions: (1) Long QTc syndrome or QTc interval > 480 ms; (2) Serious and uncontrolled arrhythmias requiring drug treatment, uncontrolled angina with poor drug control and myocardial infarction within 6 months before enrollment; (3) New York Heart Association grade III IV; (4) Cardiac ejection fraction (LVEF)< 45% Hepatitis B and hepatitis C active infection (HBV DNA above upper limit of normal; HCV antibody positive and HCV RNA above upper limit of normal) Human immunodeficiency virus (HIV) infection (HIV antibody positive) Subjects with other malignant tumors past or present (except for non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in control, and other malignant tumors that have been effectively controlled without treatment within the past five years) Subjects suffering from primary or secondary central nervous system (CNS) lymphoma pregnancy, lactation and patients of childbearing age who are unwilling to take contraceptive measures Mental patients or those who cannot obtain informed consent Unsuitable subjects for this study determined by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RCMOP<br>RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment | Drug: Mitoxantrone hydrochloride liposome injection<br>* Mitoxantrone hydrochloride liposome injection (18 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.<br>* Other names: duoenda;Drug: RiTUXimab Injection<br>* RiTUXimab Injection (375 mg/m^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.<br>* Other names: lituoxidankang;Drug: Cyclophosphamid<br>* Cyclophosphamid (750 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.<br>* Other names: huanlinxianan;Drug: Vincristine<br>* Vincristine (1.4 mg/m^2，maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.<br>* Other names: changchunxinjian;Drug: Prednisolone<br>* Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.<br>* Other names: ponisong;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | To evaluate the efficacy of anti-tumor | At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate (CRR) | To evaluate the efficacy of anti-tumor | At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days) | 
| Duration of Response (DOR) | To evaluate the efficacy of anti-tumor | CR or PR up to data cut-off (up to approximately 2 years) | 
| Progression-free survival (PFS) | To evaluate the efficacy of anti-tumor | Baseline up to data cut-off (up to approximately 2 years) | 
| Overall survival (OS) | To evaluate the efficacy of anti-tumor | Baseline up to data cut-off (up to approximately 2 years) | 
| Treatment emergent adverse events (TEAEs) | The incidence and severity of adverse events assessed by CTCAE v5.0 | The first dose up to 21 or 28 days after the last dose |