Diffuse Large B-Cell LymphomaPhase 1/2NCT06760039
Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of DLBCL
A Phase 1/2 study testing R-CMOP Regimen and R-CHOP Regimen in people with Diffuse Large B-Cell Lymphoma, run by Sun Yat-sen University at 10 sites in China.
Trial summary
This is a prospective, randomized, controlled, multicenter, phase II clinical trial to evaluate the efficacy and safety of R-CMOP versus R-CHOP in the initial treatment of low-risk and medium-risk diffuse large B-cell lymphoma (DLBCL). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- R-CMOP Regimen and R-CHOP Regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 10 sitesChina
- Study dates
- 10 Jan 2025to 30 Nov 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18,≤80 years, both male and female.
- Pathologically confirmed DLBCL
- No prior treatment for DLBCL.
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- Expected survival ≥3 months.
- International Prognostic Index (IPI) ≤ 2
- Sufficient bone marrow, liver, and kidney function.
Who cannot join
- Other types of LBCL:Primary Cutaneous Diffuse Large B-cell Lymphoma (Leg Type), Primary Mediastinal (Thymic) Large B-cell Lymphoma, Lymphomatoid Granulomatosis, ALK-positive Diffuse Large B-cell Lymphoma, Plasmablastic Lymphoma, Intravascular Large B-cell Lymphoma, T-cell/Histiocyte-rich Large B-cell Lymphoma, and others.
- Transformed DLBCL.
- Patients with central nervous system involvement, or those who require high-dose methotrexate for prevention.
- The patients had previously received antitumor therapy.
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
- Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
- Mentally ill persons or persons unable to obtain informed consent.
- The investigators think that the patient is not suitable for the study.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Not yet recruiting
Beijing Tongren Hospital
Beijing
Liang Wang, 15001108693
- Not yet recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian
Hongming He, 13799361913
- Not yet recruiting
Ganzhou Cancer Hospital
Ganzhou, Jiangxi
Qingfang Zeng, 13870711700
- Recruiting
The Fifth Affiliated Hospital of Guangzhou Medical University.
Guangzhou, Guangdong, 510060
Runhui Zheng, 13560225061
- Not yet recruiting
The Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong
Xinggui Chen, 13652859129, baisr@sysucc.org.cn
- Not yet recruiting
Guangxi Zhuang Autonomous Region Cancer Hospital
Guilin, Guangxi
Hong Cen, 13507711671
- Not yet recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu
Junfeng Jiang, 13893332604
- Not yet recruiting
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi
Wuping Li, 13870659916
- Not yet recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong
Jihao Zhou, 18718678693
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong
Nan Chen, 13631270598
About this study
Official title: Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of Low-risk and Medium-risk Diffuse Large B-cell Lymphoma (DLBCL): a Randomized, Controlled, Open-label, Multicenter, Phase Ib/II Clinical Study
This is a prospective, randomized, controlled, multicenter, phase II clinical trial to evaluate the efficacy and safety of R-CMOP versus R-CHOP in the initial treatment of low-risk and medium-risk diffuse large B-cell lymphoma (DLBCL).
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- R-CMOP Regimen, R-CHOP Regimen
- Keywords
- DLBCL, R-CHOP, Liposomal Mitoxantrone
- 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-CMOP RegimenDrug
Rituximab intravenous drip, Cyclophosphamide intravenous drip, Liposomal Mitoxantrone intravenous drip, Vincristine intravenous drip, Prednisone orally
R-CHOP RegimenDrug
Rituximab intravenous drip, Cyclophosphamide intravenous drip, Doxorubicinin intravenous drip, Vincristine intravenous drip, Prednisone orally
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | R-CMOP group Receives: Drug: R-CMOP Regimen |
| Control group | Active comparator | R-CHOP group Receives: Drug: R-CHOP Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year event-free survival (EFS) rate assessed by the independent review committee
To investigate the antitumor efficacy
Measured: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the independent review committee's assessment.
RP2D(Phase Ib)
Phase II Recommended Dose
Measured: Cycle 1 in R-CMOP group (28 days)
DLT(Phase Ib)
Dose-limiting toxicity
Measured: Cycle 1 in R-CMOP group (28 days)
Secondary outcomes (6)
2-year event-free survival (EFS) rate assessed by the investigators
To investigate the anti-tumor efficacy
Measured: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the investigators' assessment.
AE and SAE (Phase Ib)
Number of participants with adverse events (AE) and severe adverse events (SAE) in phase Ib
Measured: Up to 24 weeks
2-year Progression-free survival(PFS)
To investigate the antitumor efficacy
Measured: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
2-year Overall survival(OS)
To investigate the antitumor efficacy
Measured: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
Objective response rate (ORR)
To investigate the antitumor efficacy
Measured: Up to 24 weeks
Complete response rate (CRR)
To investigate the antitumor efficacy
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start10 Jan 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion30 Nov 2028 (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.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760039
- Sponsor's protocol ID
- B2024-737-01
- Status last verified
- Apr 2025
- First submitted
- 30 Dec 2024
- Last updated
- 3 Apr 2025
- 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 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of Low-risk and Medium-risk Diffuse Large B-cell Lymphoma (DLBCL): a Randomized, Controlled, Open-label, Multicenter, Phase Ib/II Clinical Study
- ClinicalTrials.gov ID
- NCT06760039
- Acronym / sponsor ID
- B2024-737-01
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- DLBCL, R-CHOP, Liposomal Mitoxantrone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 6 Jan 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.
This is a prospective, randomized, controlled, multicenter, phase II clinical trial to evaluate the efficacy and safety of R-CMOP versus R-CHOP in the initial treatment of low-risk and medium-risk diffuse large B-cell lymphoma (DLBCL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: R-CMOP RegimenR-CMOP group |
| Control group | Active comparator | Drug: R-CHOP RegimenR-CHOP group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥18,≤80 years, both male and female.
- Pathologically confirmed DLBCL
- No prior treatment for DLBCL.
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
Key exclusion criteria (8 listed)
- Other types of LBCL:Primary Cutaneous Diffuse Large B-cell Lymphoma (Leg Type), Primary Mediastinal (Thymic) Large B-cell Lymphoma, Lymphomatoid Granulomatosis, ALK-positive Diffuse Large B-cell Lymphoma, Plasmablastic Lymphoma, Intravascular Large B-cell Lymphoma, T-cell/Histiocyte-rich Large B-cell Lymphoma, and others.
- Transformed DLBCL.
- Patients with central nervous system involvement, or those who require high-dose methotrexate for prevention.
- The patients had previously received antitumor therapy.
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
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-CMOP RegimenRituximab intravenous drip, Cyclophosphamide intravenous drip, Liposomal Mitoxantrone intravenous drip, Vincristine intravenous drip, Prednisone orally | Drug | Experimental group |
| R-CHOP RegimenRituximab intravenous drip, Cyclophosphamide intravenous drip, Doxorubicinin intravenous drip, Vincristine intravenous drip, Prednisone orally | Drug | Control group |
Primary outcome
2-year event-free survival (EFS) rate assessed by the independent review committee
Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the independent review committee's assessment.
To investigate the antitumor efficacy
RP2D(Phase Ib)
Time frame: Cycle 1 in R-CMOP group (28 days)
Phase II Recommended Dose
DLT(Phase Ib)
Time frame: Cycle 1 in R-CMOP group (28 days)
Dose-limiting toxicity
6 secondary outcomes
2-year event-free survival (EFS) rate assessed by the investigators
Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the investigators' assessment.
AE and SAE (Phase Ib)
Time frame: Up to 24 weeks
2-year Progression-free survival(PFS)
Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
2-year Overall survival(OS)
Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
Objective response rate (ORR)
Time frame: Up to 24 weeks
Complete response rate (CRR)
Time frame: Up to 24 weeks
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 3 Apr 2025.
- 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.
10 sites 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 R-CMOP Regimen and R-CHOP Regimen in people with Diffuse Large B-Cell Lymphoma, run by Sun Yat-sen University at 10 sites 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 8 inclusion and 8 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 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 Qingqing Cai, MD. PhD. (0086-20-87342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year event-free survival (EFS) rate assessed by the independent review committee (time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the independent review committee's assessment.). The study lists 3 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 3 Apr 2025.