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 Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RCMOP RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment |
Drug: Mitoxantrone hydrochloride liposome injection
Mitoxantrone hydrochloride liposome injection (18 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
Other Names:
Drug: RiTUXimab Injection
RiTUXimab Injection (375 mg/m^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.
Other Names:
Drug: Cyclophosphamid
Cyclophosphamid (750 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
Other Names:
Drug: Vincristine
Vincristine (1.4 mg/m^2，maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
Other Names:
Drug: Prednisolone
Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Objective response rate (ORR) [At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days)]
To evaluate the efficacy of anti-tumor
Secondary Outcome Measures
- Complete response rate (CRR) [At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days)]
To evaluate the efficacy of anti-tumor
- Duration of Response (DOR) [CR or PR up to data cut-off (up to approximately 2 years)]
To evaluate the efficacy of anti-tumor
- Progression-free survival (PFS) [Baseline up to data cut-off (up to approximately 2 years)]
To evaluate the efficacy of anti-tumor
- Overall survival (OS) [Baseline up to data cut-off (up to approximately 2 years)]
To evaluate the efficacy of anti-tumor
- Treatment emergent adverse events (TEAEs) [The first dose up to 21 or 28 days after the last dose]
The incidence and severity of adverse events assessed by CTCAE v5.0
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects fully understand and voluntarily participate in this study and sign informed consent
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Age≥18 years old
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International Prognostic Index (IPI)>2
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Expected survival ≥ 3 months
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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
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Patients who were evaluated as incomplete remission after 2 cycles of RCHOP/RCDOP for initial treatment
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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
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ECOG Performance Status: 0-1
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Bone marrow function: Absolute neutrophil count ≥1.5×109/L, Platelet count ≥75×109/L, Hemoglobin ≥ 80g/L (Patients with bone marrow involvement were judged by the investigator to enter the group)
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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:
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Hypersensitivity to any study drug or its components
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Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.)
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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%
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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)
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Human immunodeficiency virus (HIV) infection (HIV antibody positive)
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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)
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Subjects suffering from primary or secondary central nervous system (CNS) lymphoma
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pregnancy, lactation and patients of childbearing age who are unwilling to take contraceptive measures
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Mental patients or those who cannot obtain informed consent
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Unsuitable subjects for this study determined by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Bethune Hospital of Jilin University | Changchun | Jilin | China | 130021 |
Sponsors and Collaborators
- The First Hospital of Jilin University
- CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSPC-DED-DLBCL-K10