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.
NCT ID: NCT05990985
Last Updated: 2023-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2023-09-01
2026-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RCMOP
RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment
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.
RiTUXimab Injection
RiTUXimab Injection (375 mg/m\^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.
Cyclophosphamid
Cyclophosphamid (750 mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
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.
Prednisolone
Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.
Interventions
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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.
RiTUXimab Injection
RiTUXimab Injection (375 mg/m\^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.
Cyclophosphamid
Cyclophosphamid (750 mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
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.
Prednisolone
Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age≥18 years old
3. International Prognostic Index (IPI)\>2
4. Expected survival ≥ 3 months
5. 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
6. Patients who were evaluated as incomplete remission after 2 cycles of RCHOP/RCDOP for initial treatment
7. 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
8. ECOG Performance Status: 0-1
9. 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)
10. 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
2. Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.)
3. 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%
4. 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)
5. Human immunodeficiency virus (HIV) infection (HIV antibody positive)
6. 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)
7. Subjects suffering from primary or secondary central nervous system (CNS) lymphoma
8. pregnancy, lactation and patients of childbearing age who are unwilling to take contraceptive measures
9. Mental patients or those who cannot obtain informed consent
10. Unsuitable subjects for this study determined by the investigator.
18 Years
ALL
No
Sponsors
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CSPC Ouyi Pharmaceutical Co., Ltd.
INDUSTRY
The First Hospital of Jilin University
OTHER
Responsible Party
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Ou Bai, MD/PHD
Director
Locations
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The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSPC-DED-DLBCL-K10
Identifier Type: -
Identifier Source: org_study_id
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