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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

A Multicenter, Prospective Phase I/II Trial to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome in Combination With Cyclophosphamide, Vincristine, Prednisone, and Rituximab in Patients With Newly Diagnosed DLBCL

R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma (NCT06594640) is a Phase 1 / Phase 2 interventional studying Diffuse Large B-cell Lymphoma, sponsored by Institute of Hematology & Blood Diseases Hospital, China. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Diffuse Large B-cell Lymphoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 108 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Diffuse Large B-cell Lymphoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥18 years; 2. diagnosed by tissue sample (biopsy-confirmed) newly diagnosed diffuse large B-cell lymphoma; 3. Patients must have been untreated, including chemotherapy, targeted therapy, immunotherapy, radiotherapy; 4. There must be at least one measurable lesion per the Lugano2014 criteria; 5. For lymph lesion, the long axis must be greater than 1.5cm with 18F-deoxyglucose (18FDG) PET-CT positive; 6. Ann Arbor stages II-IV; 7. ECOG score 0\~2; 8. Expected survival time ≥3 months; 9. 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 × 10\^9/L; platelet count at least 75 × 10\^9/L; blood count (hemoglobin) at least 80g/L. For patients with bone marrow involvement of lymphoma, the requirements are adjusted as follows: Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L; Platelet count ≥ 50 × 10\^9/L; Hemoglobin level ≥ 75 g/L. b.)Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; AST and ALT ≤ 5 × ULN for patients with liver involvement. Total bilirubin ≤1.5 × ULN (≤ 3 × ULN for patients with Gilbert syndrome); c.)kidney function (creatinine clearance) at least 50 mL/min or serum creatinine ≤ 2× ULN; d.)Coagulation function: prothrombin time or activated partial thromboplastin time≤ 1.5 × ULN, and international normalized ratio ≤ 1.5; 10. 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 least 12 months after the last treatment; 11. Able to understand and comply with the study, and voluntarily sign willing to sign a consent form; - Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age ≥18 years; 2. Histologically confirmed newly diagnosed diffuse large B-cell lymphoma; 3. Patients must have been untreated, including chemotherapy, targeted therapy, immunotherapy, radiotherapy; 4. There must be at least one measurable lesion per the Lugano2014 criteria; 5. For lymph lesion, the long axis must be greater than 1.5cm with 18F-deoxyglucose (18FDG) PET-CT positive; 6. Ann Arbor stages II-IV; 7. ECOG score 0\~2; 8. Expected survival time ≥3 months; 9. 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 × 10\^9/L; Platelet ≥ 75 × 10\^9/L; Hemoglobin≥80g/L. For patients with bone marrow involvement of lymphoma, the requirements are adjusted as follows: Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L; Platelet count ≥ 50 × 10\^9/L; Hemoglobin level ≥ 75 g/L. b.)Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; AST and ALT ≤ 5 × ULN for patients with liver involvement. Total bilirubin ≤1.5 × ULN (≤ 3 × ULN for patients with Gilbert syndrome); c.)Creatinine clearance ≥ 50 mL/min or serum creatinine ≤ 2× ULN; d.)Coagulation function: prothrombin time or activated partial thromboplastin time≤ 1.5 × ULN, and international normalized ratio ≤ 1.5; 10. 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 least 12 months after the last treatment; 11. Able to understand and comply with the study, and voluntarily sign informed consent; - Exclusion Criteria: 1. 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 lymphoma, HHV8-positive DLBCL, Primary effusion lymphoma, Intravascular large B-cell lymphoma, B-cell lymphoma unclassifiable between DLBCL and classical Hodgkin lymphoma, T-cell/histiocyte-rich large B-cell lymphoma, and High-grade B-cell lymphoma; 2. transformed indolent lymphoma ; 3. Patients with active central nervous system involvement; 4. History of hematopoietic stem cell transplantation; 5. Have received prior anti-lymphoma treatment, excluding short-term or low-dose corticosteroids.; 6. Used any NMPA-approved anticancer herbal medicines or proprietary Chinese medicines within 14 days prior to the first dose; 7. History of allergy and contraindications to the same class and excipients of the experimental drug; 8. Participating in any other intervention clinical trials within 4 weeks prior to the first dose except for participation in an observational (non-interventional) clinical study or the follow-up phase of an interventional study; 9. Active bacterial or viral infections requiring systemic or intravenous drug treatment. 10. History of immunodeficiency, including anti-HIV positive; 11. 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 RNA higher than the Upper limit of normal); 12. syphilis infection; 13. 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 reduced adherence to the study; 14. Patients with interstitial lung disease that requires treatment; 15: A history of severe cardiovascular disease, including but not limited to: 1. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, or second to third-degree atrioventricular (AV) block; 2. A mean QTcF interval longer than 450 ms, based on three 12-lead ECGs taken at rest; 3. 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; 4. NYHA functional class ≥ II or left ventricular ejection fraction (LVEF)lower than 50%; 5. 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 relative under the age of 40, or concurrent use of any medications known to prolong the QT interval; 6. 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 bladder cancer, carcinoma in situ of the cervix or breast); 17. No psychological, spiritual potentially hampering compliance with the study protocol and follow-up schedule; 18. Women who are pregnant or breastfeeding; 19. Any other reasons deemed by the investigator to render the participant unsuitable for inclusion in this clinical trial. \-

Treatments Being Tested

DRUG

Mitoxantrone Hydrochloride Liposome

assigned dose according to the 3+3 dose-escalation design in part 1, RP2D in part 2, D2

DRUG

Rituximab (R)

375mg/m2, D2

DRUG

Cyclophosphamide (CTX)

750mg/m2, D2

DRUG

Vincristin

1.2mg/m2, maximum 2mg, D2

DRUG

Prednisolone

60mg/m2, D2-6

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Institute of Hematology & Blood Disease Hospital
Tianjin, Tianjin Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06594640), the sponsor (Institute of Hematology & Blood Diseases Hospital, China), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06594640 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06594640?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06594640?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06594640. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06594640. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.