Diffuse Large B-Cell LymphomaPhase 2NCT06921044
A Study of R-mini-MCOP in the Treatment of Elderly, Previously Untreated DLBCL
A Phase 2 study testing R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone in people with Diffuse Large B-Cell Lymphoma, run by Xiaohui He.
Trial summary
Research purpose： To evaluate the efficacy and safety of R-mini-MCOP in first-line treatment of primary treatment of diffuse large B-cell lymphoma (DLBCL) in elderly patients Experimental design： Single-arm, multicenter, prospective study Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2025to 1 Mar 2027
- Phase
- Phase 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 80 years
- The histopathological diagnosis was diffuse large B-cell lymphoma, and immunohistochemistry was positive for CD20
- Previously untreated disease
- Ann Arbor stage I-IV disease
- According to Lugano2014 criteria, there must be at least one matching evaluable or measurable lesion: lymph node lesion, the length of the measurable lymph node must be greater than 1.5cm; For non-lymph node lesions, the measured extra-nodal lesions should be > 1.0cm in length;
- ECOG score 0-4(ECOG score 0-2 after pre-treatment and before R-mini-MCOP regimen)
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- Bone marrow function: neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, hemoglobin ≥80g/L (neutrophil count ≥1.0×109/L, platelet count ≥50×109/L, hemoglobin ≥75 g/L in patients with bone marrow involvement);
- 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 (≤5 times the upper limit of normal for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver invasion;
- Have the swallowing power
- Life expectancy > 3 months
- Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF) -
Who cannot join
- Previous systemic antitumor therapy (except pre-therapy used before the first cycle of R-CMOP);
- Metastatic diffuse large B-cell lymphoma；
- Known central nervous system lymphoma
- Hypersensitivity to any investigational drug or its ingredients;
- Uncontrollable systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.);
- Hepatitis B and hepatitis C active infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x103 copies /mL; More than 1x103 copies /mL of HCV RNA);
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- Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- Other serious comorbidities, intolerance to this protocol or inappropriate participation in this study (judged by the investigator)
- Previous or current co-occurrence of other malignancies (other than non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years);
- Inability to swallow the drug or any significant removal of the small intestine that may prevent full absorption of the drug;
- Situations in which other investigators have determined that participation in this study is not appropriate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Prospective Phase Ⅱ Clinical Study of R-mini-MCOP（Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone） in the Treatment of Elderly, Previously Untreated Diffuse Large B-cell Lymphoma
Research purpose： To evaluate the efficacy and safety of R-mini-MCOP in first-line treatment of primary treatment of diffuse large B-cell lymphoma (DLBCL) in elderly patients Experimental design： Single-arm, multicenter, prospective study
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone
- Keywords
- Diffuse large B-cell lymphoma，, Mitoxantrone Hydrochloride liposomal
- 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.
R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / PrednisoneDrug
Rituximab ：375 mg/m2，ivgtt，d0； Mitoxantrone Liposome ： The first dose level: 6mg/m2, ivgtt, d1; The second dose level: 8mg/m2, ivgtt, d1; The third dose level: 10mg/m2, ivgtt, d1; Cyclophosphamide :400 mg/m2，ivgtt，d1； Vincristine :1mg（，ivgtt，d1； Prednisone:40 mg/m2，po.，d1-5； Q3W
| Study group | Role | What they receive |
|---|---|---|
| R-mini-MCOP | Experimental | Rituximab ：375 mg/m2，ivgtt，d0； Mitoxantrone Liposome ： The first dose level: 6mg/m2, ivgtt, d1; The second dose level: 8mg/m2, ivgtt, d1; The third dose level: 10mg/m2, ivgtt, d1; Cyclophosphamide :400 mg/m2，ivgtt，d1； Vincristine :1mg，ivgtt，d1； Prednisone:40 mg/m2，po.，d1-5； Q3W（Every 3 Weeks） Receives: Drug: R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate （CRR）
Complete response rate at the end of induction
Measured: At the end of Cycle 2 (each cycle is 21 days)
Secondary outcomes (5)
Overall Response (CR+PR) Rate （ORR）
Overall Response (CR+PR) rate at the end of induction
Measured: At the end of Cycle 2 (each cycle is 21 days)
Duration of response (DOR)
Measured: From the date when criteria for response are met (CR or PR) until the date of progression or relapse. Patients without relapse or progression or death from other causes will be censored at their last assessment date (24 months from response date)
Progression-free survival (PFS)
Measured: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (12,24 months)
Overall Survival (OS)
Measured: Time between the date of enrolment and the date of death from any cause (12,24, 36 and 48 months)
Event Free Survival (EFS)
Measured: From the date of enrolment to the date of disease progression, relapse from CR, initiation of subsequent systemic anti-lymphoma therapy after the least 6 cycles of RI-CHOP (each cycle is 21 days), or death whichever occurs first (24, 36 and 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start16 Apr 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaohui He
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Xiaohui He, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921044
- Sponsor's protocol ID
- CSPC-DED-DLBCL-K15
- Status last verified
- Jan 2025
- First submitted
- 25 Feb 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Phase Ⅱ Clinical Study of R-mini-MCOP（Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone） in the Treatment of Elderly, Previously Untreated Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06921044
- Acronym / sponsor ID
- CSPC-DED-DLBCL-K15
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- Diffuse large B-cell lymphoma，, Mitoxantrone Hydrochloride liposomal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Xiaohui HeUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 16 Apr 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 10 Apr 2025 (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.
Research purpose： To evaluate the efficacy and safety of R-mini-MCOP in first-line treatment of primary treatment of diffuse large B-cell lymphoma (DLBCL) in elderly patients Experimental design： Single-arm, multicenter, prospective study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-mini-MCOP | Experimental | Drug: R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / PrednisoneRituximab ：375 mg/m2，ivgtt，d0； Mitoxantrone Liposome ： The first dose level: 6mg/m2, ivgtt, d1; The second dose level: 8mg/m2, ivgtt, d1; The third dose level: 10mg/m2, ivgtt, d1; Cyclophosphamide :400 mg/m2，ivgtt，d1； Vincristine :1mg，ivgtt，d1； Prednisone:40 mg/m2，po.，d1-5； Q3W（Every 3 Weeks） |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Age ≥ 80 years
- The histopathological diagnosis was diffuse large B-cell lymphoma, and immunohistochemistry was positive for CD20
- Previously untreated disease
- Ann Arbor stage I-IV disease
- According to Lugano2014 criteria, there must be at least one matching evaluable or measurable lesion: lymph node lesion, the length of the measurable lymph node must be greater than 1.5cm; For non-lymph node lesions, the measured extra-nodal lesions should be > 1.0cm in length;
Key exclusion criteria (11 listed)
- Previous systemic antitumor therapy (except pre-therapy used before the first cycle of R-CMOP);
- Metastatic diffuse large B-cell lymphoma；
- Known central nervous system lymphoma
- Hypersensitivity to any investigational drug or its ingredients;
- Uncontrollable systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.);
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 |
|---|---|---|
| R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / PrednisoneRituximab ：375 mg/m2，ivgtt，d0； Mitoxantrone Liposome ： The first dose level: 6mg/m2, ivgtt, d1; The second dose level: 8mg/m2, ivgtt, d1; The third dose level: 10mg/m2, ivgtt, d1; Cyclophosphamide :400 mg/m2，ivgtt，d1； Vincristine :1mg（，ivgtt，d1； Prednisone:40 mg/m2，po.，d1-5； Q3W | Drug | R-mini-MCOP |
Primary outcome
Complete response rate （CRR）
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Complete response rate at the end of induction
5 secondary outcomes
Overall Response (CR+PR) Rate （ORR）
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Duration of response (DOR)
Time frame: From the date when criteria for response are met (CR or PR) until the date of progression or relapse. Patients without relapse or progression or death from other causes will be censored at their last assessment date (24 months from response date)
Progression-free survival (PFS)
Time frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (12,24 months)
Overall Survival (OS)
Time frame: Time between the date of enrolment and the date of death from any cause (12,24, 36 and 48 months)
Event Free Survival (EFS)
Time frame: From the date of enrolment to the date of disease progression, relapse from CR, initiation of subsequent systemic anti-lymphoma therapy after the least 6 cycles of RI-CHOP (each cycle is 21 days), or death whichever occurs first (24, 36 and 48 months)
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 Apr 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone in people with Diffuse Large B-Cell Lymphoma, run by Xiaohui He.
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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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 Sheng Yang (13683260156, medart@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate （CRR） (time frame: At the end of Cycle 2 (each cycle is 21 days)). 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 Apr 2025.