Diffuse Large B-cell LymphomaPhase 1/2NCT06594640
R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma
A Phase 1/2 study testing Mitoxantrone Hydrochloride Liposome, Rituximab (R) and Cyclophosphamide (CTX) in people with Diffuse Large B-cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Mitoxantrone Hydrochloride Liposome, Rituximab (R) and Cyclophosphamide (CTX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2024to 30 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
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- 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 × 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;
- 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;
- Able to understand and comply with the study, and voluntarily sign informed consent; -
Who cannot join
- 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；
- 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;
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- 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-interventional) clinical study or the follow-up phase of an interventional 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 RNA higher than the Upper limit of normal);
- 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 reduced adherence to the study;
- 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 relative under the age of 40, or concurrent use of any medications known to prolong the QT interval;
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Disease Hospital
Tianjin, Tianjin Municipality, 300020
Wei Liu, MD, 86-022-23908463, liuwei@ihcams.ac.cn
Wei Liu, MD
About this study
Official title: 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
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
Read the detailed description
This is an open, multicenter, prospective phase I/II clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with cyclophosphamide, vincristine, prednisone, and rituximab (R-CMOP) in patients with newly diagnosed diffuse large B-cell lymphoma. The study is divided into two parts. The first part uses a 3+3 dose-escalation design, in which mitoxantrone hydrochloride liposome injection in the R-CMOP regimen will be administered at three different doses: 16 mg/m², 18 mg/m², and 20 mg/m², to determine the recommended Phase 2 dose (RP2D). The second part follows a single-arm design to evaluate the efficacy and safety of the R-CMOP regimen, with mitoxantrone hydrochloride liposome injection administered at the RP2D. Each cycle consists of 21 days. A maximum of 6 cycles of therapy are planned.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Mitoxantrone Hydrochloride Liposome, Rituximab (R), Cyclophosphamide (CTX), Vincristin, Prednisolone
- Keywords
- Mitoxantrone hydrochloride liposome injection, Diffuse Large B-cell Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone Hydrochloride LiposomeDrug
assigned dose according to the 3+3 dose-escalation design in part 1, RP2D in part 2, D2
Rituximab (R)Drug
375mg/m2, D2
Cyclophosphamide (CTX)Drug
750mg/m2, D2
VincristinDrug
1.2mg/m2, maximum 2mg， D2
PrednisoloneDrug
60mg/m2, D2-6
| Study group | Role | What they receive |
|---|---|---|
| R-CMOP | Experimental | R-CMOP regimen includes rituximab (R), cyclophosphamide (C), mitoxantrone hydrochloride liposome injection (M), vincristine (O), and prednisone (P).
The regimen will be administered every 3 weeks, for a maximum of 6 cycles. Receives: Drug: Mitoxantrone Hydrochloride Liposome; Drug: Rituximab (R); Drug: Cyclophosphamide (CTX); Drug: Vincristin; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I:Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride in R-CMOP
Measured: Through the last patient complete his DLT observation, assessed up to 21 days
Phase I: Recommended phaseII dose (RP2D)
The Recommended Phase II Dose (RP2D) is defined as the optimal dose of liposomal mitoxantrone hydrochloride for use in Phase II trials, as determined by the outcomes of the Phase I study.
Measured: Through the last patient complete his DLT observation, assessed up to 21 days
Phase II:Complete remission rate (CRR)
Response is assessed according to the lugano criteria
Measured: up to 2 years
Phase I: Dose limited toxicities (DLTs)
adverse events defined as DLT events per protocol
Measured: Through the last patient complete his DLT observation, assessed up to 21 days
Secondary outcomes (11)
Phase I: The incidence rates of adverse events (AEs)
AE or severe adverse events (SAE) occur since the first dose of therapy is given
Measured: up to 2 years
Phase I: Objective response rate (ORR)
Response is assessed according to the lugano criteria
Measured: up to 2 years
Phase I: Complete remission rate (CRR)
Response is assessed according to the lugano criteria
Measured: up to 2 years
Phase II: Overall response rate (ORR)
Response is assessed according to the lugano criteria
Measured: up to 2 years
Phase II: Partial response rate (PRR)
Response is assessed according to the lugano criteria
Measured: up to 2 years
Phase II: Duration of response (DOR)
DOR was defined as the time from first complete response or partial response to disease progression or death from any causes.
Measured: up to 2 years
Phase II: Progression-free survival (PFS)
From the date of the first dose of therapy is given until disease progression or death from any cause.
Measured: up to 2 years
Phase II: Overall survival (OS)
From the date of inclusion to date of death, irrespective of cause
Measured: up to 2 years
Phase II: Disease-free survival (DFS)
From the date of achieving a complete response until disease progression or death from any cause.
Measured: up to 2 years
Phase II: Event-free survival (EFS)
From the date of the first dose of therapy is given until disease progression, death , or the initiation of a new treatment regimen.
Measured: up to 2 years
Phase II: The incidence rates of adverse events (AEs)
AE or severe adverse events (SAE) occur since the first dose of therapy is given
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 May 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lugui Qiu, Professor, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594640
- Sponsor's protocol ID
- IIT2024014
- Status last verified
- Jun 2026
- First submitted
- 5 Sep 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06594640
- Acronym / sponsor ID
- IIT2024014
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Mitoxantrone hydrochloride liposome injection, Diffuse Large B-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is an open, multicenter, prospective phase I/II clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with cyclophosphamide, vincristine, prednisone, and rituximab (R-CMOP) in patients with newly diagnosed diffuse large B-cell lymphoma. The study is divided into two parts. The first part uses a 3+3 dose-escalation design, in which mitoxantrone hydrochloride liposome injection in the R-CMOP regimen will be administered at three different doses: 16 mg/m², 18 mg/m², and 20 mg/m², to determine the recommended Phase 2 dose (RP2D). The second part follows a single-arm design to evaluate the efficacy and safety of the R-CMOP regimen, with mitoxantrone hydrochloride liposome injection administered at the RP2D. Each cycle consists of 21 days. A maximum of 6 cycles of therapy are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-CMOP | Experimental | Drug: Mitoxantrone Hydrochloride Liposome, Drug: Rituximab (R), Drug: Cyclophosphamide (CTX), Drug: Vincristin, Drug: PrednisoloneR-CMOP regimen includes rituximab (R), cyclophosphamide (C), mitoxantrone hydrochloride liposome injection (M), vincristine (O), and prednisone (P). The regimen will be administered every 3 weeks, for a maximum of 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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；
Key exclusion criteria (22 listed)
- 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；
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoxantrone Hydrochloride Liposomeassigned dose according to the 3+3 dose-escalation design in part 1, RP2D in part 2, D2 | Drug | R-CMOP |
| Rituximab (R)375mg/m2, D2 | Drug | R-CMOP |
| Cyclophosphamide (CTX)750mg/m2, D2 | Drug | R-CMOP |
| Vincristin1.2mg/m2, maximum 2mg， D2 | Drug | R-CMOP |
| Prednisolone60mg/m2, D2-6 | Drug | R-CMOP |
Primary outcome
Phase I:Maximum tolerated dose (MTD)
Time frame: Through the last patient complete his DLT observation, assessed up to 21 days
Maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride in R-CMOP
Phase I: Recommended phaseII dose (RP2D)
Time frame: Through the last patient complete his DLT observation, assessed up to 21 days
The Recommended Phase II Dose (RP2D) is defined as the optimal dose of liposomal mitoxantrone hydrochloride for use in Phase II trials, as determined by the outcomes of the Phase I study.
Phase II:Complete remission rate (CRR)
Time frame: up to 2 years
Response is assessed according to the lugano criteria
Phase I: Dose limited toxicities (DLTs)
Time frame: Through the last patient complete his DLT observation, assessed up to 21 days
adverse events defined as DLT events per protocol
11 secondary outcomes
Phase I: The incidence rates of adverse events (AEs)
Time frame: up to 2 years
Phase I: Objective response rate (ORR)
Time frame: up to 2 years
Phase I: Complete remission rate (CRR)
Time frame: up to 2 years
Phase II: Overall response rate (ORR)
Time frame: up to 2 years
Phase II: Partial response rate (PRR)
Time frame: up to 2 years
Phase II: Duration of response (DOR)
Time frame: up to 2 years
Phase II: Progression-free survival (PFS)
Time frame: up to 2 years
Phase II: Overall survival (OS)
Time frame: up to 2 years
Phase II: Disease-free survival (DFS)
Time frame: up to 2 years
Phase II: Event-free survival (EFS)
Time frame: up to 2 years
Phase II: The incidence rates of adverse events (AEs)
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lugui Qiu, Professor principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mitoxantrone Hydrochloride Liposome, Rituximab (R) and Cyclophosphamide (CTX) in people with Diffuse Large B-cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Liu (+86-022-23608461, liuwei@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I:Maximum tolerated dose (MTD) (time frame: Through the last patient complete his DLT observation, assessed up to 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.