Clinical trial NCT05990985: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diffuse Large B-cell Lymphoma
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: CSPC Ouyi Pharmaceutical Co., Ltd.
First posted: 2023-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days)
Secondary outcomes:
measure: Complete response rate (CRR)
timeFrame: At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days)
measure: Duration of Response (DOR)
timeFrame: CR or PR up to data cut-off (up to approximately 2 years)
measure: Progression-free survival (PFS)
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
measure: Overall survival (OS)
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
measure: Treatment emergent adverse events (TEAEs)
timeFrame: The first dose up to 21 or 28 days after the last dose
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
Study officials:
References: