Diffuse Large B-cell Lymphoma
Conditions
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.
Interventions
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 (375 mg/m\^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.
DRUGCyclophosphamid
Cyclophosphamid (750 mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
DRUGVincristine
Vincristine (1.4 mg/m\^2，maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
DRUGPrednisolone
Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.
Sponsors
CSPC Ouyi Pharmaceutical Co., Ltd.
The First Hospital of Jilin University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects fully understand and voluntarily participate in this study and sign informed consent 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
1. Hypersensitivity to any study drug or its components 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactOu Bai, PHD
Outcome results
None listed