CMOP±R therapy for newly diagnosed non-Hodgkin's lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm Phase 2 trial evaluating the safety and efficacy of mitoxantrone hydrochloride liposome combined with CMOP±R (cyclophosphamide, vincristine, prednisone and/or rituximab) in untreated NHL patients. Participants receive up to eight 28-day cycles, with mitoxantrone liposome given on day 1 at 18 mg/m2 per cycle. The study will monitor for adverse events and treatment responses using standard criteria, focusing on measurable disease and overall tolerance. Eligibility requires adults 18-75 with ECOG 0-2 and adequate organ function, and at least one evaluable lesion per Lugano 2014 criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Haiwen Huang — The First Affiliated Hospital of Soochow University, Suzhou, China
• Study coordinator: Haiwen Huang
• Email: huanghaiwen@suda.edu.cn
• Phone: 13962154846

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HSK47977 tablets for adults with relapsed or refractory non-Hodgkin's lymphoma.

  This Phase 1 study will test whether oral HSK47977 tablets are safe, how the body handles them, and whether they help adults with relapsed or refractory non-Hodgkin's lymphoma.

  Recruiting Phase 1 Haisco Pharmaceutical Group Co., Ltd. · Tianjin · NCT07283796

• Testing FD-001 for recurrent or refractory blood cancers

  This study is testing a new medication called FD-001 to see if it can help people with tough-to-treat blood cancers like acute myeloid leukemia and non-Hodgkin lymphoma.

  Recruiting Phase 1 Chengdu FenDi Pharmaceutical Co., Ltd. · Chengdu, Sichuan · NCT06731699

• IDP-023 treatment for advanced blood cancers

  This study is testing a new treatment called IDP-023, which uses special immune cells alone and with other medications to see if it can help people with advanced blood cancers like multiple myeloma and non-Hodgkin lymphoma.

  Recruiting at 9 sites Phase 1/2 Indapta Therapeutics, INC. · Los Angeles, California and 11 other locations · NCT06119685

• Evaluating IM19 CAR-T cell therapy for patients with recurrent Non-Hodgkin's Lymphoma

  This study is testing a new CAR-T cell therapy called IM19 to see if it can safely help adults with recurrent Non-Hodgkin's Lymphoma.

  Recruiting Phase 1/2 Beijing Immunochina Medical Science & Technology Co., Ltd. · Beijing, Beijing Municipality · NCT04440436

• Combining acalabrutinib with standard chemotherapy for untreated aggressive B-cell lymphoma

  This study is testing if adding a new drug called acalabrutinib to standard chemotherapy can help people with untreated aggressive B-cell lymphoma get better results.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT04002947

• ALA-101 in CD19+ blood cancers

  A small early-phase test to see if ALA-101, an off-the-shelf CAR-iNKT cell therapy, is safe and potentially effective in adults with CD19-positive NHL or leukemia.

  Recruiting Phase 1 Arovella Therapeutics Ltd · Sydney, New South Wales and 4 other locations · NCT07518329

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.