Lymphoma, Large B-Cell, DiffusePhase 3NCT06573645
A Phase III Clinical Trial of High-dose Rituximab (500mg/m²) Combined With CHOP Regimen in the Treatment of Male Patient With Newly Diagnosed Advanced DLBCL
A Phase 3 study testing Rituximab in people with Lymphoma, Large B-Cell, Diffuse, run by Xia Yi.
Trial summary
Comparison of MODIFIED progression-free survival (Modified-PFS) in high-dose rituximab (500mg/m²) plus CHOP versus standard-dose rituximab plus CHOP in previously untreated (TN) stage III-IV male DLBCL patients Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- No sites listed yet
- Study dates
- 23 Aug 2024to 12 Jul 2027
- Phase
- Phase 3
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age <75y, male patients
- According to the 2017 Revised WHO Classification criteria for lymphoma, the subject was diagnosed with DLBCL
- According to Ann Arbor staging, patients were classified as stage III-IV patients
- No previous anti-tumor systemic therapy or local radiation therapy for DLBCL
- Expected survival ≥6 months
- Have sufficient coagulation function and liver and kidney function
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- Haver sufficient bone marrow function
- All patients should take medically approved contraceptive measures within 12 months after rituximab administration (specific circumstances should follow the listed drug label)
- Subjects were enrolled voluntarily, signed informed consent, and followed the experimental treatment protocol and visit plan
Who cannot join
- Subjects assessed by the investigator to be intolerant to the R-CHOP regimen and/or any drug therapy;
- Any previous anti-lymphoma systemic therapy or local radiation therapy
- Consider patients with lymphoma involving the central nervous system (CNS) or diagnosed with primary CNS lymphoma (PCNSL); The diagnosis was primary mediastinal large B-cell lymphoma (PMBL)
- Previously received organ transplantation or hematopoietic stem cell transplantation
- Had received major surgery or major trauma within 4 weeks before the first medication (or before randomization), and had participated in clinical trials of non-anti-tumor drugs or medical devices within 4 weeks
- Have had malignant tumors other than the indications targeted in this study in the past three years
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- Participants with any serious and/or uncontrolled systemic disease who are determined by the investigator to be unsuitable for participation in the study
- Major cardiovascular disease occurred within 6 months before the first medication (or before randomization)
- Any conditions that affect the patient's ingestion of the drug, as well as conditions that seriously affect the absorption or pharmacokinetic parameters of the drug in the trial, including difficult to control nausea and vomiting, short bowel syndrome, etc.
- Subjects who received live or attenuated vaccine within 4 weeks prior to initial administration (or prior to randomization) or planned to receive live vaccine during the study period or 4 weeks after the end of study treatment
- A hemorrhagic disease (such as von Willebrand disease or hemophilia A, hemophilia B, etc.) or according to the judgment of the investigator has a clear bleeding tendency
- have a serious peripheral nervous system or central nervous system disease.
- Warfarin or other vitamin K antagonists are required during the study
- There is an autoimmune disease that cannot be controlled or requires treatment within 4 weeks prior to the first dose (or prior to randomization)
- Doxorubicin has been used in the past ≥150 mg/m2
- The investigator believes that the subjects have other conditions that are not suitable for participation in this experiment.
About this study
Official title: A Phase III Randomized Controlled Study Comparing High-dose Rituximab (500 mg/m²) Combined With CHOP Regimen Versus Standard-dose Rituximab (375 mg/m²) Combined With CHOP Regimen in Male Patients With Newly Diagnosed Advanced Diffuse Large B-cell Lymphoma
Comparison of MODIFIED progression-free survival (Modified-PFS) in high-dose rituximab (500mg/m²) plus CHOP versus standard-dose rituximab plus CHOP in previously untreated (TN) stage III-IV male DLBCL patients
Read the detailed description
This study is a multicenter, randomized, controlled Phase III clinical trial that primarily evaluates the modified progression-free survival (MODIFIED-PFS) in previously untreated male DLBCL patients treated with high-dose rituximab (500mg/m²) combined with the CHOP regimen compared to standard-dose rituximab combined with the CHOP regimen. After signing the informed consent and before randomization, all participants must provide sufficient tumor tissue biopsy samples for confirmation of DLBCL via central laboratory tests such as HE staining and IHC. Eligible participants are randomized in a 1:1 ratio to either the experimental group (rituximab 500 mg/m2) or the control group (rituximab 375 mg/m2) and will receive 6 cycles of R-CHOP treatment (21 days per cycle), followed by 2 additional cycles of maintenance therapy with rituximab (21 days per cycle).
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Being tested
- Rituximab
- Keywords
- lymphoma, Diffuse large B cell lymphoma, High doses rituximab
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Patients will be randomized to receive either rituximab 500 mg/m2 or rituximab 375 mg/m2 for six cycles of R-CHOP (21 days per cycle), followed by two maintenance cycles of rituximab (21 days per cycle).
| Study group | Role | What they receive |
|---|---|---|
| High-dose Rituximab Group | Experimental | Patients will be assigned to the trial group (rituximab 500 mg/m2) and will receive six cycles of R-CHOP (21 days per cycle), followed by two maintenance cycles of rituximab (21 days per cycle). Receives: Drug: Rituximab |
| Standard-dose Rituximab Group | Active comparator | Patients will be assigned to the control group (rituxan 375 mg/m2), the participants will receive 6 cycles R - CHOP treatment (21 d for a cycle), and the subsequent 2 cycle rituxan maintenance therapy (21 d for a cycle) Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
MODIFIED-PFS
To investigate the preliminary anti-tumor efficacy
Measured: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Secondary outcomes (3)
Overall survival (OS)
To investigate the preliminary anti-tumor efficacy
Measured: From the date of enrollment until the date of death from ant cause, assessed up to 48 months
Complete response rate (CRR)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 8 cycles (each cycle is 21 days)
Objective response rate (ORR)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 8 cycles (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start23 Aug 2024 (estimated)
- Primary completion12 Jan 2027 (estimated)
- Study completion12 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A non-repetitive stratified block randomization method is used, with the treatment assignment codes for participants (randomization table) being generated by a blinded statistician in a 1:1 ratio. The randomization table is then uploaded to the central randomization system for configuration. Once a participant's eligibility is confirmed, the researcher logs into the central randomization system, enters the participant's information, and obtains the participant's random number and drug code. The researcher administers the corresponding study treatment based on the drug code. Participants are randomized in a 1:1 ratio to either the experimental group (rituximab 500 mg/m²) or the control group (rituximab 375 mg/m²).
- Masking
- None (open label)
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xia Yi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xia Yi, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573645
- Sponsor's protocol ID
- B2024-380
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Controlled Study Comparing High-dose Rituximab (500 mg/m²) Combined With CHOP Regimen Versus Standard-dose Rituximab (375 mg/m²) Combined With CHOP Regimen in Male Patients With Newly Diagnosed Advanced Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06573645
- Acronym / sponsor ID
- B2024-380
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Keywords
- lymphoma, Diffuse large B cell lymphoma, High doses rituximab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- Xia YiUniversity, hospital or other
- Study start
- 23 Aug 2024 (estimated)
- Primary completion
- 12 Jan 2027 (estimated)
- Study completion
- 12 Jul 2027 (estimated)
- First posted
- 27 Aug 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.
Comparison of MODIFIED progression-free survival (Modified-PFS) in high-dose rituximab (500mg/m²) plus CHOP versus standard-dose rituximab plus CHOP in previously untreated (TN) stage III-IV male DLBCL patients
Detailed description
This study is a multicenter, randomized, controlled Phase III clinical trial that primarily evaluates the modified progression-free survival (MODIFIED-PFS) in previously untreated male DLBCL patients treated with high-dose rituximab (500mg/m²) combined with the CHOP regimen compared to standard-dose rituximab combined with the CHOP regimen. After signing the informed consent and before randomization, all participants must provide sufficient tumor tissue biopsy samples for confirmation of DLBCL via central laboratory tests such as HE staining and IHC. Eligible participants are randomized in a 1:1 ratio to either the experimental group (rituximab 500 mg/m2) or the control group (rituximab 375 mg/m2) and will receive 6 cycles of R-CHOP treatment (21 days per cycle), followed by 2 additional cycles of maintenance therapy with rituximab (21 days per cycle).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A non-repetitive stratified block randomization method is used, with the treatment assignment codes for participants (randomization table) being generated by a blinded statistician in a 1:1 ratio. The randomization table is then uploaded to the central randomization system for configuration. Once a participant's eligibility is confirmed, the researcher logs into the central randomization system, enters the participant's information, and obtains the participant's random number and drug code. The researcher administers the corresponding study treatment based on the drug code. Participants are randomized in a 1:1 ratio to either the experimental group (rituximab 500 mg/m²) or the control group (rituximab 375 mg/m²).
| Arm | Type | Receives |
|---|---|---|
| High-dose Rituximab Group | Experimental | Drug: RituximabPatients will be assigned to the trial group (rituximab 500 mg/m2) and will receive six cycles of R-CHOP (21 days per cycle), followed by two maintenance cycles of rituximab (21 days per cycle). |
| Standard-dose Rituximab Group | Active comparator | Drug: RituximabPatients will be assigned to the control group (rituxan 375 mg/m2), the participants will receive 6 cycles R - CHOP treatment (21 d for a cycle), and the subsequent 2 cycle rituxan maintenance therapy (21 d for a cycle) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age <75y, male patients
- According to the 2017 Revised WHO Classification criteria for lymphoma, the subject was diagnosed with DLBCL
- According to Ann Arbor staging, patients were classified as stage III-IV patients
- No previous anti-tumor systemic therapy or local radiation therapy for DLBCL
- Expected survival ≥6 months
Key exclusion criteria (16 listed)
- Subjects assessed by the investigator to be intolerant to the R-CHOP regimen and/or any drug therapy;
- Any previous anti-lymphoma systemic therapy or local radiation therapy
- Consider patients with lymphoma involving the central nervous system (CNS) or diagnosed with primary CNS lymphoma (PCNSL); The diagnosis was primary mediastinal large B-cell lymphoma (PMBL)
- Previously received organ transplantation or hematopoietic stem cell transplantation
- Had received major surgery or major trauma within 4 weeks before the first medication (or before randomization), and had participated in clinical trials of non-anti-tumor drugs or medical devices within 4 weeks
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 |
|---|---|---|
| RituximabPatients will be randomized to receive either rituximab 500 mg/m2 or rituximab 375 mg/m2 for six cycles of R-CHOP (21 days per cycle), followed by two maintenance cycles of rituximab (21 days per cycle). | Drug | High-dose Rituximab Group, Standard-dose Rituximab Group |
Primary outcome
MODIFIED-PFS
Time frame: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
To investigate the preliminary anti-tumor efficacy
3 secondary outcomes
Overall survival (OS)
Time frame: From the date of enrollment until the date of death from ant cause, assessed up to 48 months
Complete response rate (CRR)
Time frame: Up to 8 cycles (each cycle is 21 days)
Objective response rate (ORR)
Time frame: Up to 8 cycles (each cycle is 21 days)
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 27 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab in people with Lymphoma, Large B-Cell, Diffuse, run by Xia Yi.
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 9 inclusion and 16 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 27 Aug 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MODIFIED-PFS (time frame: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 48 months). 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 27 Aug 2024.