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New treatment option for Diffuse Large B-cell Lymphoma
Official title R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT06594640
What this study is testing
What is Mitoxantrone Hydrochloride Liposome?
Mitoxantrone Hydrochloride Liposome is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diffuse large b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective clinical study to evaluate the safety and efficacy of R-CMOP in patients with newly diagnosed diffuse large B-cell lymphoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years;
- Histologically confirmed newly diagnosed diffuse large B-cell lymphoma;
- Patients must have been untreated, including chemotherapy, targeted therapy, immunotherapy, radiotherapy;
- There must be at least one measurable lesion per the Lugano2014 criteria；
- For lymph lesion, the long axis must be greater than 1.5cm with 18F-deoxyglucose (18FDG) PET-CT positive；
You likely can't join if
- Primary central nervous system DLBCL, Primary testicular large B-cell lymphoma, Primary mediastinal (thymic) large B-cell lymphoma, Lymphomatoid...
- transformed indolent lymphoma ;
- Patients with active central nervous system involvement;
- History of hematopoietic stem cell transplantation;
- Have received prior anti-lymphoma treatment, excluding short-term or low-dose corticosteroids.;
- Used any NMPA-approved anticancer herbal medicines or proprietary Chinese medicines within 14 days prior to the first dose;
See the full eligibility criteria
- Age ≥18 years;
- Histologically confirmed newly diagnosed diffuse large B-cell lymphoma;
- Patients must have been untreated, including chemotherapy, targeted therapy, immunotherapy, radiotherapy;
- There must be at least one measurable lesion per the Lugano2014 criteria；
- For lymph lesion, the long axis must be greater than 1.5cm with 18F-deoxyglucose (18FDG) PET-CT positive；
- Ann Arbor stages II-IV；
- ECOG score 0\~2；
- Expected survival time ≥3 months;
- a.)Patients should meet the following requirements and must not have received treatment with cell growth factors or blood products within 14 days prior to the hematology test: Absolute value of neutrophils ≥ 1.5 ×...
- Female patients of childbearing age must have a negative pregnancy test at the time of enrollment within one week. And patients must agree to use an effective method of contraception from the study initiation until at...
- Able to understand and comply with the study, and voluntarily sign informed consent; -
- Primary central nervous system DLBCL, Primary testicular large B-cell lymphoma, Primary mediastinal (thymic) large B-cell lymphoma, Lymphomatoid granulomatosis, ALK-positive large B-cell lymphoma, Plasmablastic...
- transformed indolent lymphoma ;
- Patients with active central nervous system involvement;
- History of hematopoietic stem cell transplantation;
- Have received prior anti-lymphoma treatment, excluding short-term or low-dose corticosteroids.;
- Used any NMPA-approved anticancer herbal medicines or proprietary Chinese medicines within 14 days prior to the first dose;
- History of allergy and contraindications to the same class and excipients of the experimental drug;
- Participating in any other intervention clinical trials within 4 weeks prior to the first dose except for participation in an observational (non-treatment) clinical study or the follow-up phase of an treatment study;
- Active bacterial or viral infections requiring systemic or intravenous drug treatment.
- History of immunodeficiency, including anti-HIV positive;
- Active hepatitis B and C infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than the Upper limit of normal(ULN); Hepatitis C virus antibody positive and hepatitis C virus...
- syphilis infection;
- Individuals with an underlying medical condition, alcohol or drug abuse or dependence that impedes study drug administration or interferes with interpretation of study drug toxicity and AE, or results in inadequate or...
- Patients with interstitial lung disease that requires treatment; 15: A history of severe cardiovascular disease, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, or second to third-degree atrioventricular (AV) block;
- A mean QTcF interval longer than 450 ms, based on three 12-lead ECGs taken at rest;
- Acute coronary syndrome, congestive heart failure, stroke, or any other Grade 3 or higher cardiovascular event occurring within 6 months prior to the first dose of therapy;
- NYHA functional class ≥ II or left ventricular ejection fraction (LVEF)lower than 50%;
- Any factors that increase the risk of QTc prolongation or arrhythmias, such as heart failure, hypokalemia, congenital long QT syndrome, a family history of long QT syndrome or unexplained sudden death in a first-degree...
- uncontrolled hypertension; 16\. History of other malignant tumor within 2 years, except for DLBCL in this trial or resected locally cancer that has been cured (e.g.basal cell or squamous cell skin cancer, superficial...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.