Marginal Zone LymphomaNCT06478472
Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local Therapy
A study testing Orelabrutinib in combination with rituximab in people with Marginal Zone Lymphoma, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
Orelabrutinib combined with rituximab (OR) therapy were used to assess the efficacy and safety for newly diagnosed Marginal zone cell lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marginal Zone Lymphoma
- What is being tested?
- Orelabrutinib in combination with rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2024to 23 Jun 2027
- Phase
- Interventional
- 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 old, gender is not limited;
- Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL;
- Indications for treatment: impact on organ function, development of symptoms associated with lymphoma, large masses, hematopenia secondary to lymphoma;
- MZL that has progressed, relapsed, or is unsuitable for local therapy after prior local therapy (local therapy includes surgery, radiotherapy, anti-Helicobacter pylori therapy, anti-hepatitis C therapy);
- ECOG 0-2;
- Must have at least one measurable or evaluable lesion using the Lugano 2014 Lymphoma Efficacy Evaluation Criteria: i.e., PET/CT with an evaluable lesion; an intranodal lesion with a long diameter greater than 1.5 cm and a short diameter greater than 1.0 cm or an extranodal lesion with a long diameter of > 1.0 cm, as assessed by CT or MR
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- Participants with splenic MZL who do not meet the above criteria for radiologically measurable disease are eligible, provided that the bone marrow infiltration of the MZL is histologically confirmed;
- HBV-positive serology (concealed carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) are eligible for enrollment only if they have a negative HBV-DNA test;
- Major organ function meets the following criteria: a) Blood routine: absolute neutrophil value ≥1.5×109/L, platelet ≥75×109/L, hemoglobin ≥75g/L; if accompanied by bone marrow invasion, absolute neutrophil value ≥1.0×109/L, platelet ≥50×109/L, hemoglobin ≥50g/L; b) Blood biochemistry: total bilirubin ≤1.5 times the ULN, AST or ALT ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; serum amylase ≤ ULN; c) Coagulation function: International Normalized Ratio (INR) ≤ 1.5 times ULN. 10) Expected survival ≥ 3 months;
- Voluntary written informed consent prior to trial screening.
Who cannot join
- Lymphoma with CNS involvement or high grade transformation;
- HIV-positive patients and or HCV-active infection (documented by HCV-RNA-positive test);
- History of deep vein thrombosis or pulmonary embolism within the last 6 months;
- Active bleeding within 2 months prior to screening, or taking anticoagulant medications, or in the opinion of the investigator, a definite bleeding tendency
- Continuous use of drugs with moderate to severe inhibition or strong induction of cytochrome P450 CYP3A;
- Severe chronic obstructive pulmonary disease (COPD) with hypoxemia.
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- Active bacterial, fungal, or viral infections uncontrolled by systemic therapy;
- In addition to cured basal cell carcinoma of the skin or cervical cancer in situ or early prostate cancer not requiring systemic therapy, or early breast cancer requiring surgery alone. Other malignant tumors within the last 2 years or concurrently;
- Uncontrolled or significant cardiovascular disease, including: a) New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose of study drug, or an arrhythmia requiring treatment with a left ventricular ejection fraction (LVEF) of <50% at the time of Screening; b) primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, hypertrophic cardiomyopathy, cardiomyopathy, cardiomyopathy, cardiomyopathy, cardiomegaly, cardiomyopathy, cardiomegaly) b) Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy); c) A history of clinically significant prolongation of the QTc interval, or QTc intervals of >470 ms in women and >450 ms in men at Screening; d) Subjects with symptomatic or medically-treated coronary artery heart disease; e) Subjects with difficult-to-control high blood pressure (as determined by a reasonable and tolerable dose of adequate medications based on lifestyle improvement). (blood pressure remains uncontrolled for more than 1 month despite the application of a reasonably tolerable and adequate dose of 3 or more antihypertensive medications (including diuretics) on the basis of lifestyle improvement, or blood pressure is not effectively controlled until 4 or more antihypertensive medications have been administered);
- Subjects with clinically significant gastrointestinal abnormalities that may interfere with drug ingestion, transit, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy;
- Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening. A major surgical procedure is one in which general anesthesia is used, but endoscopy for diagnostic purposes is not considered a major surgical procedure. Insertion of vascular access devices will be exempt from this exclusion criterion; ;
- Subjects who use drugs or alcohol;
- Pregnant, lactating females and subjects of childbearing age who do not wish to use contraception;
- known hypersensitivity or allergic reaction to murine antibodies or proteins
- Any mental or cognitive impairment that may limit understanding, implementation, and compliance with the informed consent form;
- Previous treatment with BTK, BCR pathway inhibitors (e.g., PI3K, Syk), and BCL-2 inhibitors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Orelabrutinib combined with rituximab (OR) therapy were used to assess the efficacy and safety for newly diagnosed Marginal zone cell lymphoma
- Conditions
- Marginal Zone Lymphoma
- Being tested
- Orelabrutinib in combination with rituximab
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orelabrutinib in combination with rituximabDrug
Induction Phase:
Orelabrutinib + rituximab for a total of 6 cycles of 28 days each Obrutinib (O) 150mg oral d1-28 Rituximab (R) 375mg/m2 IV d0
Maintenance phase:
Orelabrutinib 150mg po qd 24 cycles of 28 days each
| Study group | Role | What they receive |
|---|---|---|
| OR | Experimental | Orelabrutinib in combination with rituximab Receives: Drug: Orelabrutinib in combination with rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR
Complete remission rate (according to Lugano 2014 criteria)
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start23 Jun 2024
- Primary completion23 Jun 2027 (estimated)
- Study completion23 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Zone LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University, Fujian Cancer Hospital, Guangdong Provincial People's Hospital, Nanfang Hospital, Southern Medical University, The Second Affiliated Hospital of Dalian Medical University, Jiangxi Provincial Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shanxi Province Cancer Hospital, Chinese PLA General Hospital
- Responsible party
- Principal investigator, Bing, Xu, The First Affiliated Hospital of Xiamen University
- Investigators
- Bing Xu, Principal investigator, The First Aiffiliated hosptical of xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478472
- Sponsor's protocol ID
- XMDYYYXYK-09
- Status last verified
- Jul 2024
- First submitted
- 23 Jun 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local Therapy
- ClinicalTrials.gov ID
- NCT06478472
- Acronym / sponsor ID
- XMDYYYXYK-09
- Conditions
- Marginal Zone Lymphoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University, Fujian Cancer Hospital, Guangdong Provincial People's Hospital, Nanfang Hospital, Southern Medical University, The Second Affiliated Hospital of Dalian Medical University, Jiangxi Provincial Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shanxi Province Cancer Hospital, Chinese PLA General Hospital
- Study start
- 23 Jun 2024 (actual)
- Primary completion
- 23 Jun 2027 (estimated)
- Study completion
- 23 Jun 2027 (estimated)
- First posted
- 27 Jun 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.
Orelabrutinib combined with rituximab (OR) therapy were used to assess the efficacy and safety for newly diagnosed Marginal zone cell lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OR | Experimental | Drug: Orelabrutinib in combination with rituximabOrelabrutinib in combination with rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: ≥18 years old, gender is not limited;
- Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL;
- Indications for treatment: impact on organ function, development of symptoms associated with lymphoma, large masses, hematopenia secondary to lymphoma;
- MZL that has progressed, relapsed, or is unsuitable for local therapy after prior local therapy (local therapy includes surgery, radiotherapy, anti-Helicobacter pylori therapy, anti-hepatitis C therapy);
- ECOG 0-2;
Key exclusion criteria (16 listed)
- Lymphoma with CNS involvement or high grade transformation;
- HIV-positive patients and or HCV-active infection (documented by HCV-RNA-positive test);
- History of deep vein thrombosis or pulmonary embolism within the last 6 months;
- Active bleeding within 2 months prior to screening, or taking anticoagulant medications, or in the opinion of the investigator, a definite bleeding tendency
- Continuous use of drugs with moderate to severe inhibition or strong induction of cytochrome P450 CYP3A;
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 |
|---|---|---|
| Orelabrutinib in combination with rituximabInduction Phase: Orelabrutinib + rituximab for a total of 6 cycles of 28 days each Obrutinib (O) 150mg oral d1-28 Rituximab (R) 375mg/m2 IV d0 Maintenance phase: Orelabrutinib 150mg po qd 24 cycles of 28 days each | Drug | OR |
Primary outcome
CR
Time frame: Up to 36 months
Complete remission rate (according to Lugano 2014 criteria)
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 29 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Marginal Zone Lymphoma
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Active, not recruitingPhase 2
PET/CT-Guided Maintenance Therapy in Previously Untreated MZL
Marginal Zone Lymphoma(MZL)
Active, not recruitingPhase 1/2
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
DLBCL, High-grade B-cell Lymphoma (HGBCL)
Active, not recruitingPhase 1/2
Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)
Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
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.
Bing Xu principal investigator
The First Aiffiliated hosptical of xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orelabrutinib in combination with rituximab in people with Marginal Zone Lymphoma, run by The First Affiliated Hospital of Xiamen 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: looking for participants now, as of the sponsor's last update on 29 Jul 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.
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 Bing Xu, PhD (18750918842, xubingzhangjian@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR (time frame: Up to 36 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 29 Jul 2024.