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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.

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mitoxantrone hydrochloride liposome injection
RiTUXimab Injection
Cyclophosphamid
Vincristine
Prednisolone
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

  • The First Bethune Hospital of Jilin University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RCMOP

Arm Description

RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
To evaluate the efficacy of anti-tumor

Secondary Outcome Measures

Complete response rate (CRR)
To evaluate the efficacy of anti-tumor
Duration of Response (DOR)
To evaluate the efficacy of anti-tumor
Progression-free survival (PFS)
To evaluate the efficacy of anti-tumor
Overall survival (OS)
To evaluate the efficacy of anti-tumor
Treatment emergent adverse events (TEAEs)
The incidence and severity of adverse events assessed by CTCAE v5.0

Full Information

First Posted
August 7, 2023
Last Updated
August 15, 2023
Sponsor
The First Hospital of Jilin University
Collaborators
CSPC Ouyi Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05990985
Brief 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.
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Hospital of Jilin University
Collaborators
CSPC Ouyi Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RCMOP
Arm Type
Experimental
Arm Description
RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone hydrochloride liposome injection
Other Intervention Name(s)
duoenda
Intervention Description
Mitoxantrone hydrochloride liposome injection (18 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
Intervention Type
Drug
Intervention Name(s)
RiTUXimab Injection
Other Intervention Name(s)
lituoxidankang
Intervention Description
RiTUXimab Injection (375 mg/m^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamid
Other Intervention Name(s)
huanlinxianan
Intervention Description
Cyclophosphamid (750 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
changchunxinjian
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
ponisong
Intervention Description
Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
To evaluate the efficacy of anti-tumor
Time Frame
At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days)
Secondary Outcome Measure Information:
Title
Complete response rate (CRR)
Description
To evaluate the efficacy of anti-tumor
Time Frame
At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days)
Title
Duration of Response (DOR)
Description
To evaluate the efficacy of anti-tumor
Time Frame
CR or PR up to data cut-off (up to approximately 2 years)
Title
Progression-free survival (PFS)
Description
To evaluate the efficacy of anti-tumor
Time Frame
Baseline up to data cut-off (up to approximately 2 years)
Title
Overall survival (OS)
Description
To evaluate the efficacy of anti-tumor
Time Frame
Baseline up to data cut-off (up to approximately 2 years)
Title
Treatment emergent adverse events (TEAEs)
Description
The incidence and severity of adverse events assessed by CTCAE v5.0
Time Frame
The first dose up to 21 or 28 days after the last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ou Bai, PHD
Phone
13039046656
Email
oubai16@163.com
Facility Information:
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ou Bai, PHD
Phone
13039046656
Email
oubai16@163.com

12. IPD Sharing Statement

Learn more about this trial

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.

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