CMOP±R in the Treatment of Untreated Non-Hodgkin's Lymphoma

NCT ID: NCT06486337

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2027-08-31

Brief Summary

This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOP±R in patients with newly diagnosed non-Hodgkin's lymphoma.

Detailed Description

This is a single-arm, open label, multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with Cyclophosphamide, Vincristine, Prednisone and/or Rituximab(CMOP±R) in patients with newly diagnosed non-Hodgkin's lymphoma. Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with cyclophosphamide, vincristine, prednisone and/or Rituximab. Each cycle consists of 28 days. A maximum of 8 cycles(6×CMOP±R+2×R) of therapy are planned.

Conditions

NHL

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CMOP±R

All enrolled patients. All patient who signed the consent form for participation to the study.

Group Type: EXPERIMENTAL

CMOP±R

Intervention Type: DRUG

Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (18 mg/m\^2) on day 1, every 4 weeks; Drug: Cyclophosphamide Cyclophosphamide(750 mg/m\^2) on day 1, every 4 weeks; Drug: Vincristine Vincristine (1.4mg/ m2，Max dose 2mg) will be administered on day 1(Or at the discretion of the investigator, use other vinblastine drugs with the same mechanism, such as vindesine 2-3 mg/m2 on day 1), every 4 weeks; Drug: Prednisone Prednisone (100 mg) will be taken orally from day 1-5(Or equivalent dose of dexamethasone at 15mg), every 4 weeks; Drug: Rituximab Rituximab (375mg/m\^2) on day 0, every 4 weeks, only with CD20-positive lymphomas are evaluated by the investigator.

Interventions

CMOP±R

Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (18 mg/m\^2) on day 1, every 4 weeks; Drug: Cyclophosphamide Cyclophosphamide(750 mg/m\^2) on day 1, every 4 weeks; Drug: Vincristine Vincristine (1.4mg/ m2，Max dose 2mg) will be administered on day 1(Or at the discretion of the investigator, use other vinblastine drugs with the same mechanism, such as vindesine 2-3 mg/m2 on day 1), every 4 weeks; Drug: Prednisone Prednisone (100 mg) will be taken orally from day 1-5(Or equivalent dose of dexamethasone at 15mg), every 4 weeks; Drug: Rituximab Rituximab (375mg/m\^2) on day 0, every 4 weeks, only with CD20-positive lymphomas are evaluated by the investigator.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients fully understand this study, voluntarily participate and sign the informed consent (ICF);
• Age: 18-75 years old;
• Expected survival time ≥ 3 months;
• Histopathologically diagnosed newly diagnosed non-Hodgkin's lymphoma;
• Must have at least one evaluable or measurable lesion that meets the Lugano 2014 criteria: lymph node lesions, measurable lymph nodes must have a long diameter >1.5cm; non-lymph node lesions, measurable extranodal lesions must have a long diameter >1.0cm;
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
• Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10^9/L, Platelet count (PLT) ≥75×10^9/L, Hemoglobin(HB)≥ 80 g/L(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×10^9/L, Platelet count (PLT) ≥50×10^9/L, Hemoglobin(HB)≥ 75g/L);
• Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal value (for patients with liver invasion ≤ 5 times the upper limit of normal value); total bilirubin ≤ 1.5 times the upper limit of normal value (for patients with liver invasion ≤ 3 times the upper limit of normal value);

Exclusion Criteria

• Subjects have previously received anthracyclic drug pretreatment;
• Hypersensitivity to any study drug or its components;
• Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.);
• Heart function and disease meet one of the following conditions: a) long QTc syndrome or QTc interval >480 ms; b) complete left bundle branch block, grade II or III atrioventricular block; c) Serious and uncontrolled arrhythmias requiring drug treatment; d) New York Heart Association grade ≥ III; e) Cardiac ejection fraction (LVEF) lower than 50%;f) A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.
• Active hepatitis B and C infection (positive hepatitis B virus surface antigen and more than 1x10^3 copies/mL of hepatitis B virus DNA; more than 1x10^3 copies/mL of hepatitis C virus RNA);
• Human immunodeficiency virus (HIV) infection (positive HIV antibody);
• Suffering from other malignant tumors in the past or at the same time (except for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervix carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment in the past five years);
• Suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment;
• Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
• Other researchers judge not to Eligibility to participate in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haiwen Huang

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University, Suzhou, China

Central Contacts

Haiwen Huang

Role: CONTACT

huanghaiwen@suda.edu.cn

13962154846

Haiwen Huang

Role: CONTACT

Other Identifiers

CSPC-DED-NHL-K03

Identifier Type: -

Identifier Source: org_study_id