Diffuse Large B Cell Lymphoma (DLBCL)Phase 2NCT06594432
Molecular Subtype-Guided R-CHOP-MTX±Zanubrutinib Treatment in Newly Diagnosed DLBCL Patients with Central Nervous System Involvement
A Phase 2 study testing R-CHOP+Z+MTX and R-CHOP+MTX in people with Diffuse Large B Cell Lymphoma (DLBCL), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Evaluate the Efficacy and Safety of R-CHOP-MTX±Zanubrutinib in Newly Diagnosed Diffuse Large B-Cell Lymphoma Patients with Central Nervous System Involvement, and Explore the Efficacy Indicators of CSF-ctDNA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- R-CHOP+Z+MTX and R-CHOP+MTX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2024to Jun 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤80 years, regardless of gender;
- Patients with pathologically confirmed, previously untreated diffuse large B-cell lymphoma (DLBCL) who are CSF-ctDNA positive for secondary CNS lymphoma (SCNSL);
- MRI or CT of the brain showing substantial lesions in the central nervous system; patients with only meningeal lesions must have CSF cytology confirming lymphoma cells and/or imaging findings consistent with CSF examination;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3;
- Organ function levels meeting the following requirements:Absolute neutrophil count ≥1.5×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥90g/L (if bone marrow is involved, platelets ≥50×10^9/L).
- Liver function: ALT and AST ≤2.5 times the upper limit of normal, total bilirubin ≤2 times the upper limit of normal.
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- 8.Renal function: creatinine ≤1.5 times the upper limit of normal; creatinine clearance rate ≥40 ml/min (assessed according to the Cockcroft-Gault formula or the estimated glomerular filtration rate [eGFR] from the Modification of Diet in Renal Disease [MDRD] formula).
- 9.Coagulation function: International Normalized Ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN.
- 10.Expected survival time \>3 months; 11.No radiotherapy, chemotherapy, or antibody therapy within 3 weeks before medication; no targeted therapy within 10 days before medication; 12.Female subjects of childbearing potential must agree to use effective contraception during the study and for at least 90 days after the last dose of the study drug. Male subjects must be sterilized, i.e., vasectomy, or use barrier methods, while their female partners use the aforementioned effective contraception.
- 13.Signed written informed consent before trial screening.
Who cannot join
- Previous treatment with BTK inhibitors;
- Received targeted therapy within 10 days before starting the study drug, or systemic chemotherapy, radiotherapy, or antibody therapy within 3 weeks before starting the study drug;
- Abnormal liver function (total bilirubin \>2 times the normal value, ALT or AST \>2.5 times the normal value), abnormal renal function (serum creatinine \>1.5 times the normal value);
- Currently have clinically significant active cardiovascular disease, such as uncontrolled arrhythmias, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within 6 months before screening;
- QTcF \>450 msecs or other significant ECG abnormalities, including second-degree type II atrioventricular (AV) block or third-degree AV block;
- Previous chemotherapy with unresolved toxicity (toxicity not resolved to ≤ grade 1 according to NCI-CTCAE 5.0, except for alopecia, absolute neutrophil count (ANC), and platelets);
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- Patients with active bleeding;
- Patients with active infections or persistent fever within 14 days before enrollment (excluding tumor-related fever);
- Patients with active HBV, HCV, and HIV infections;
- Patients with serous cavity effusion;
- Patients who have not completed 4 weeks after major organ surgery;
- Patients receiving strong inhibitors or strong inducers of cytochrome P450 family 3 subfamily A (CYP3A);
- Pregnant or lactating women and patients of childbearing potential who are unwilling to use contraception;
- Patients with mental disorders/unable to obtain informed consent;
- Patients who abuse drugs or have long-term alcoholism that affects the evaluation of trial results;
- Patients deemed unsuitable for participation in this study by the investigator.
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
Hematological Department, People's Hospital of Jiangsu Province
Nanjing, Jiangsu, 210029
Wei Xu, PhD, +86-2568302182, xuwei10000@hotmail.com
About this study
Official title: A Study on the Efficacy and Safety of Molecular Subtype-Guided R-CHOP-MTX±Zanubrutinib Treatment in Newly Diagnosed DLBCL Patients with Central Nervous System Involvement
Evaluate the Efficacy and Safety of R-CHOP-MTX±Zanubrutinib in Newly Diagnosed Diffuse Large B-Cell Lymphoma Patients with Central Nervous System Involvement, and Explore the Efficacy Indicators of CSF-ctDNA.
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Being tested
- R-CHOP+Z+MTX, R-CHOP+MTX
- 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-CHOP+Z+MTXDrug
After receiving 1 cycle of pre-treatment with the R-CHOP regimen, patients with CSF-ctDNA (+) and MCD, BN2, and N1 subtypes will receive 5 cycles of R-CHOP combined with MTX + Zanubrutinib, followed by 1 cycle of R-MTX-Zanubrutinib.
After completing the above induction therapy, Patients with negative CSF-ctDNA results will continue with one more cycle of Rituximab. For patients with positive CSF-ctDNA results, the investigator will decide to continue treatment with Rituximab one more cycle combined with Temozolomide, Pomalidomide, or Lenalidomide, etc., until CSF-ctDNA turns negative.
Each combined regimen consists of a 21-day treatment cycle, and efficacy will be evaluated every three treatment cycles.
R-CHOP+MTXDrug
After receiving 1 cycle of pre-treatment with the R-CHOP regimen, patients with CSF-ctDNA (+) and EZB, A53, and other gene subtypes will receive 5 cycles of R-CHOP combined with MTX, followed by 1 cycle of R-MTX.
After completing the above induction therapy, Patients with negative CSF-ctDNA results will continue with one more cycle of Rituximab. For patients with positive CSF-ctDNA results, the investigator will decide to continue treatment with Rituximab one more cycle combined with Temozolomide, Pomalidomide, or Lenalidomide, etc., until CSF-ctDNA turns negative.
Each combined regimen consists of a 21-day treatment cycle, and efficacy will be evaluated every three treatment cycles.
| Study group | Role | What they receive |
|---|---|---|
| MCD, BN2, and N1 subtypes | Other | Not described Receives: Drug: R-CHOP+Z+MTX |
| EZB, A53, and other gene subtypes | Other | Not described Receives: Drug: R-CHOP+MTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF-ctDNA negativity rate at the end of induction therapy (EOT)
Measured: At the end of induction therapy (EOT), an average of 6 months
Secondary outcomes (4)
Progression Free Survival（PFS）
Measured: 2 years
Complete Response Rate（CR）
Measured: End of treatment visit (after last dose of Cycle 7 [Cycle length=21 days]）
Overall Survival（OS）
Measured: up to approximately 24 months
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From enrollment to study completion, a maximum of 24 months
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 startOct 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 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 Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI XU, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Wei Xu, Principal investigator, The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594432
- Sponsor's protocol ID
- 2024-SR-433
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Molecular Subtype-Guided R-CHOP-MTX±Zanubrutinib Treatment in Newly Diagnosed DLBCL Patients with Central Nervous System Involvement
- ClinicalTrials.gov ID
- NCT06594432
- Acronym / sponsor ID
- 2024-SR-433
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 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.
Evaluate the Efficacy and Safety of R-CHOP-MTX±Zanubrutinib in Newly Diagnosed Diffuse Large B-Cell Lymphoma Patients with Central Nervous System Involvement, and Explore the Efficacy Indicators of CSF-ctDNA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCD, BN2, and N1 subtypes | Other | Drug: R-CHOP+Z+MTX |
| EZB, A53, and other gene subtypes | Other | Drug: R-CHOP+MTX |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years and ≤80 years, regardless of gender;
- Patients with pathologically confirmed, previously untreated diffuse large B-cell lymphoma (DLBCL) who are CSF-ctDNA positive for secondary CNS lymphoma (SCNSL);
- MRI or CT of the brain showing substantial lesions in the central nervous system; patients with only meningeal lesions must have CSF cytology confirming lymphoma cells and/or imaging findings consistent with CSF examination;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3;
- Organ function levels meeting the following requirements:Absolute neutrophil count ≥1.5×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥90g/L (if bone marrow is involved, platelets ≥50×10^9/L).
Key exclusion criteria (16 listed)
- Previous treatment with BTK inhibitors;
- Received targeted therapy within 10 days before starting the study drug, or systemic chemotherapy, radiotherapy, or antibody therapy within 3 weeks before starting the study drug;
- Abnormal liver function (total bilirubin \>2 times the normal value, ALT or AST \>2.5 times the normal value), abnormal renal function (serum creatinine \>1.5 times the normal value);
- Currently have clinically significant active cardiovascular disease, such as uncontrolled arrhythmias, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within 6 months before screening;
- QTcF \>450 msecs or other significant ECG abnormalities, including second-degree type II atrioventricular (AV) block or third-degree AV block;
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-CHOP+Z+MTXAfter receiving 1 cycle of pre-treatment with the R-CHOP regimen, patients with CSF-ctDNA (+) and MCD, BN2, and N1 subtypes will receive 5 cycles of R-CHOP combined with MTX + Zanubrutinib, followed by 1 cycle of R-MTX-Zanubrutinib. After completing the above induction therapy, Patients with negative CSF-ctDNA results will continue with one more cycle of Rituximab. For patients with positive CSF-ctDNA results, the investigator will decide to continue treatment with Rituximab one more cycle combined with Temozolomide, Pomalidomide, or Lenalidomide, etc., until CSF-ctDNA turns negative. Each combined regimen consists of a 21-day treatment cycle, and efficacy will be evaluated every three treatment cycles. | Drug | MCD, BN2, and N1 subtypes |
| R-CHOP+MTXAfter receiving 1 cycle of pre-treatment with the R-CHOP regimen, patients with CSF-ctDNA (+) and EZB, A53, and other gene subtypes will receive 5 cycles of R-CHOP combined with MTX, followed by 1 cycle of R-MTX. After completing the above induction therapy, Patients with negative CSF-ctDNA results will continue with one more cycle of Rituximab. For patients with positive CSF-ctDNA results, the investigator will decide to continue treatment with Rituximab one more cycle combined with Temozolomide, Pomalidomide, or Lenalidomide, etc., until CSF-ctDNA turns negative. Each combined regimen consists of a 21-day treatment cycle, and efficacy will be evaluated every three treatment cycles. | Drug | EZB, A53, and other gene subtypes |
Primary outcome
CSF-ctDNA negativity rate at the end of induction therapy (EOT)
Time frame: At the end of induction therapy (EOT), an average of 6 months
4 secondary outcomes
Progression Free Survival（PFS）
Time frame: 2 years
Complete Response Rate（CR）
Time frame: End of treatment visit (after last dose of Cycle 7 [Cycle length=21 days]）
Overall Survival（OS）
Time frame: up to approximately 24 months
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From enrollment to study completion, a maximum of 24 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 19 Sep 2024.
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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.
Wei Xu principal investigator
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-CHOP+Z+MTX and R-CHOP+MTX in people with Diffuse Large B Cell Lymphoma (DLBCL), run by The First Affiliated Hospital with Nanjing Medical University 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 10 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 19 Sep 2024. 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 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 Jinhua Liang, PhD (15952032421, 1151525490@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF-ctDNA negativity rate at the end of induction therapy (EOT) (time frame: At the end of induction therapy (EOT), an average of 6 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 19 Sep 2024.