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.

Trial Title: 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

Condition: Diffuse Large B-cell Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Prednisolone
Cyclophosphamide
Rituximab
Vincristine
Mitoxantrone

Study type: Interventional

Study phase: N/A

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: Mitoxantrone hydrochloride liposome injection
Description: Mitoxantrone hydrochloride liposome injection (18 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
Arm group label: RCMOP

Other name: duoenda

Intervention type: Drug
Intervention name: RiTUXimab Injection
Description: RiTUXimab Injection (375 mg/m^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.
Arm group label: RCMOP

Other name: lituoxidankang

Intervention type: Drug
Intervention name: Cyclophosphamid
Description: Cyclophosphamid (750 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
Arm group label: RCMOP

Other name: huanlinxianan

Intervention type: Drug
Intervention name: Vincristine
Description: Vincristine (1.4 mg/m^2，maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
Arm group label: RCMOP

Other name: changchunxinjian

Intervention type: Drug
Intervention name: Prednisolone
Description: Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.
Arm group label: RCMOP

Other name: ponisong

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The First Bethune Hospital of Jilin University

Address:
City: Changchun
Zip: 130021
Country: China

Contact:
Last name: Ou Bai, PHD

Phone: 13039046656
Email: oubai16@163.com

Start date: September 1, 2023

Completion date: August 1, 2026

Lead sponsor:
Agency: The First Hospital of Jilin University
Agency class: Other

Collaborator:
Agency: CSPC Ouyi Pharmaceutical Co., Ltd.
Agency class: Industry

Source: The First Hospital of Jilin University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05990985