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

NCT06486337 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CSPC-DED-NHL-K03
• Study Type: interventional
• Target: 197
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NHL

Keywords

newly diagnosed non-Hodgkin's lymphoma; Mitoxantrone hydrochloride liposome

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CRR)

  Response is assessed according to the 2014 lugano criteria.Percentage of participants with complete response was determined on 2014 Lugano criteria.

  3 years

Secondary Outcomes (7)

• Overall Response Rate (ORR)

  3 years

• Progression-Free-Survival (PFS)

  3 years

• Duration of Response (DOR)

  3 years

• Overall survival (OS)

  3 years

• Progression of disease within 2 years(POD24)

  3 years

Study Arms (1)

CMOP±R

EXPERIMENTAL

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

Drug: CMOP±R

Interventions

CMOP±R 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.

CMOP±R

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Officials

• Haiwen Huang

  The First Affiliated Hospital of Soochow University, Suzhou, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiwen Huang

CONTACT

13962154846; huanghaiwen@suda.edu.cn

Haiwen Huang

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: July 3, 2024
• Study Start: July 10, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share