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.

NCT05990985 | Not Yet Recruiting

• 1 other identifier: CSPC-DED-DLBCL-K10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  To evaluate the efficacy of anti-tumor

  At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days)

Secondary Outcomes (5)

• Complete response rate (CRR)

  At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days)

• Duration of Response (DOR)

  CR or PR up to data cut-off (up to approximately 2 years)

• Progression-free survival (PFS)

  Baseline up to data cut-off (up to approximately 2 years)

• Overall survival (OS)

  Baseline up to data cut-off (up to approximately 2 years)

• Treatment emergent adverse events (TEAEs)

  The first dose up to 21 or 28 days after the last dose

Study Arms (1)

RCMOP

EXPERIMENTAL

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

Drug: Mitoxantrone hydrochloride liposome injection; Drug: RiTUXimab Injection; Drug: Cyclophosphamid; Drug: Vincristine; Drug: Prednisolone

Interventions

Mitoxantrone hydrochloride liposome injection DRUG

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

Also known as: duoenda

RCMOP

RiTUXimab Injection DRUG

RiTUXimab Injection (375 mg/m\^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.

Also known as: lituoxidankang

RCMOP

Cyclophosphamid DRUG

Cyclophosphamid (750 mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.

Also known as: huanlinxianan

RCMOP

Vincristine DRUG

Vincristine (1.4 mg/m\^2，maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.

Also known as: changchunxinjian

RCMOP

Prednisolone DRUG

Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.

Also known as: ponisong

RCMOP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Cyclophosphamide; Vincristine; Prednisolone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Ou Bai, PHD

CONTACT

13039046656; oubai16@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2023
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

CN (1)