Status:
NOT_YET_RECRUITING
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.
Lead Sponsor:
The First Hospital of Jilin University
Collaborating Sponsors:
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ly...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05990985
Start Date
September 1 2023
End Date
August 1 2026
Last Update
August 18 2023
Active Locations (1)
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1
The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130021