OR Regimen for Relapsed/Refractory Marginal Zone LymphomaPhase 4NCT06134284
Clinical Study of OR for Second-line Treatment of Refractory MZL
A Phase 4 study testing Orelabrutinib combined with rituximab in people with OR Regimen for Relapsed/Refractory Marginal Zone Lymphoma, run by Lixia Sheng at 3 sites in China.
Trial summary
The goal of this clinical trial is to test the overall response rate of Orelabrutinib combined with rituximab (OR regimen) for second-line treatment of relapsed/refractory marginal zone lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- OR Regimen for Relapsed/Refractory Marginal Zone Lymphoma
- What is being tested?
- Orelabrutinib combined 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
- 39 participants
- Where
- 3 sitesChina
- Study dates
- 2 Jan 2023to 31 Dec 2029
- Phase
- Phase 4
- 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, 80, Sex gender no limitied;
- histological confirmation of MZL, For splenic marginal zone lymphoma (SMZL) where histological specimens of the spleen were not available, Requirements to meet the minimum diagnostic criteria for SMZL, And exclude any other type of small B cell lymphoma, That is, requiring a definite diagnosis of MZL;
- at least one two-dimensional measurable lymph node lesion (CT scan or MR / display maximum diameter> 1.5cm), Or at least one two-dimensional measurable extranodal lesion (CT scan or MRI showing maximum diameter> 1.0cm);
- the investigator required systemic treatment for marginal zone lymphoma;
- at least 1 previous course of systemic lymphoma treatment (including previous immunotherapy or chemoimmunotherapy), 3 without efficacy above PR after imaging evaluation, Or disease progression after effective treatment;
- ECOG, physical strength score 0-2;
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- primary organ function meets the following criteria 7 days prior to treatment:
- blood routine: absolute neutrophil ≥1.5x10^9 / L, Platelet≥ 75x10^9 / L, Hemoglobin≥75g / L; If the concomitant bone marrow invasion, Absolute neutrophil value ≥1.0x10^9 / L, Platelet≥50x10^9 / L, Hemoglobin≥ 50g / L;
- Blood Chemistry: total bilirubin ≤1.5 times ULN, AST or ALT ≤2 times ULN; If the liver is infiltrated with a lymphoma, Then, ALT and AST ≤5 times ULN, Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥45 ml/min (Cockcroft-Gault formula); Serum amylase ≤ULN;
- coagulation function: International normalized ratio (INR) ≤1.5 times ULN, Activated partial thromboplastin time (APTT)≤ 1.5 times ULN.
- cardiac color ultrasound: left ventricular ejection fraction 50%;
- expected survival time of 3 months;
- for men who did not undergo sterilization: agree to use the barrier contraceptive method during treatment and for at least 3 months after the last administration of obutinib or rituximab or on the older) as required in the guidelines established by the institution. In addition, male patients must agree to request their spouses to use other methods of contraception (e. g., oral contraceptives, intrauterine devices, barrier contraception, or spermicide).
- For women who did not undergo sterilization: at least 28 days prior to consent to start study medication, during treatment, or after last administration of obutinib or rituximab, such as oral contraceptives, intrauterine devices or barrier contraception;
- voluntarily signed written informed consent before test screening.
Who cannot join
- The patient had been previously treated with obutinib in combination with rituximab, Efficacy was assessed as being refractory, Infraciness was defined as no remission (PR or CR) after start of treatment 4
- history of severe allergy or allergic reaction to monoclonal antibody therapy
- known to be allergic to any study drug
- current or previous other malignancy, Unless curative treatment with no evidence of recurrence and metastasis in nearly 5 years;
- lymphoma involvement of the central nervous system;
- uncontrolled or important cardiovascular disease, Includes:
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- occurrence of New York Cardiology Association (NYHA) grade II or above congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first administration of study drug, Or the presence of significant arrhythmias requiring treatment at screening (e. g., persistent rapid AF, persistent ventricular tachycardia, ventricular fibrillation, tip torsion, history of second-degree II AV (AV) block, or history of third-degree AV block), Left ventricular ejection fraction (LVEF) <50%;
- primary cardiomyopathy (e. g. dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, irregular cardiomyopathy);
- history of clinically significant QTc interval extension, Or subjects with coronary heart disease with QTc interval female> 470ms and male> 450ms;
- symptomatic or requiring medication;
- difficult-to-control hypertension (on the basis of improved lifestyle, With an adequate amount of 2 or more antihypertensive drugs (including diuretics) for more than 1 month, Or take 4 or more antihypertensive drugs to effectively control blood pressure).
- Active bleeding within the 2 months prior to screening, Or are taking anticoagulant drugs, Or if the investigator considers a definite bleeding tendency;
- urine protein 2 +, And 24-hour urinary protein quantification of 2g / 24 hours;
- a history of deep vein thrombosis or pulmonary embolism;
- clinically obvious gastrointestinal abnormalities, May affect drug intake, transport, or absorption (e. g. inability to swallow, chronic diarrhea, intestinal obstruction, etc.), Or subjects with total gastrectomy;
- history of organ transplantation or allogeneic bone marrow transplantation;
- major surgery within 6 weeks or minor surgery within 2 weeks before screening. Major surgery is using general anesthesia, but diagnostic endoscopy is not considered a major surgical procedure. The insertion of a vascular access device will be exempted from this exclusion criteria;
- active infection or uncontrolled HBV (HBV DNA titer of 10 ^ 3 copies / ml), HCVAb positive, HI V/A IDS (Acquired Immune Deficiency Syndrome) or other serious infectious diseases;
- subjects with current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc.;
- Previous treatment with BTK, BCR, pathway inhibitors (such as PI3K, Syk), and BCL-2 kinase inhibitors;
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital
Hangzhou, Zhejiang, 310009
Wenbin Qian, Doctor, 86-571-87581969, qianwb@zju.edu.cn
- Recruiting
86-574-87085596
Ningbo, Zhejiang, 315010
Lixia Sheng, doctor, 86-574-87085596, slx800408@163.com
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
Lixia Sheng, doctor, 86-574-87085596, slx800408@163.com
About this study
Official title: Prospective, Multicenter, Single-arm Clinical Study of Orelabrutinib Plus Rituximab for Second-line Treatment of Relapsed/Refractory Marginal Zone Lymphoma
The goal of this clinical trial is to test the overall response rate of Orelabrutinib combined with rituximab (OR regimen) for second-line treatment of relapsed/refractory marginal zone lymphoma.
- Being tested
- Orelabrutinib combined 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 combined with rituximabDrug
This is a single-arm trial. Patients with relapsed/refractory marginal zone lymphoma will be treated with the OR regimen. The treatment plan is as follows: Orelabrutinib 150mg oral administration once a day, Day 1-21; Rituximab 375mg/m² intravenous infusion, Day 1. Each cycle is 21 days. PET-CT evaluation will be conducted after 4 cycles. If a partial response (PR) or better is achieved, the patient will receive further treatment with the OR regimen for an additional 4 cycles before transitioning to single-agent maintenance therapy with either rituximab or obinutuzumab. If a PR or better is not achieved after 4 cycles, the patient will discontinue from the trial.
| Study group | Role | What they receive |
|---|---|---|
| OR regimen | Experimental | The specific medication regimen for the OR regimen is as follows: Orelabrutinib 150mg orally once daily; Rituximab 375mg/m² intravenous infusion, administered every 21 days. Receives: Drug: Orelabrutinib combined with rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Proportion of CR and PR subjects will be assessed at 8 courses
Measured: up to 8 months
Secondary outcomes (3)
Progress free survival time
To measure the duration of response over a follow-up period of 36 months
Measured: up to36 months
Overall survival
OS will be assessed from the first receptor given to death or last follow-up.
Measured: up to36 months
Adverse events profile
Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated.
Measured: Measured from start of treatment until 21 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start2 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OR Regimen for Relapsed/Refractory Marginal Zone 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lixia Sheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lixia Sheng, Ningbo No. 1 Hospital
- Investigators
- Chen, Principal investigator, First Affiliated Hospital of Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134284
- Sponsor's protocol ID
- Ningbo102
- Status last verified
- Jun 2024
- First submitted
- 12 Nov 2023
- Last updated
- 11 Jun 2024
- Results posted
- 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single-arm Clinical Study of Orelabrutinib Plus Rituximab for Second-line Treatment of Relapsed/Refractory Marginal Zone Lymphoma
- ClinicalTrials.gov ID
- NCT06134284
- Acronym / sponsor ID
- Ningbo102
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Lixia ShengUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Nov 2023 (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.
The goal of this clinical trial is to test the overall response rate of Orelabrutinib combined with rituximab (OR regimen) for second-line treatment of relapsed/refractory marginal zone 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 regimen | Experimental | Drug: Orelabrutinib combined with rituximabThe specific medication regimen for the OR regimen is as follows: Orelabrutinib 150mg orally once daily; Rituximab 375mg/m² intravenous infusion, administered every 21 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age: 18 years, 80, Sex gender no limitied;
- histological confirmation of MZL, For splenic marginal zone lymphoma (SMZL) where histological specimens of the spleen were not available, Requirements to meet the minimum diagnostic criteria for SMZL, And exclude any other type of small B cell lymphoma, That is, requiring a definite diagnosis of MZL;
- at least one two-dimensional measurable lymph node lesion (CT scan or MR / display maximum diameter> 1.5cm), Or at least one two-dimensional measurable extranodal lesion (CT scan or MRI showing maximum diameter> 1.0cm);
- the investigator required systemic treatment for marginal zone lymphoma;
- at least 1 previous course of systemic lymphoma treatment (including previous immunotherapy or chemoimmunotherapy), 3 without efficacy above PR after imaging evaluation, Or disease progression after effective treatment;
Key exclusion criteria (20 listed)
- The patient had been previously treated with obutinib in combination with rituximab, Efficacy was assessed as being refractory, Infraciness was defined as no remission (PR or CR) after start of treatment 4
- history of severe allergy or allergic reaction to monoclonal antibody therapy
- known to be allergic to any study drug
- current or previous other malignancy, Unless curative treatment with no evidence of recurrence and metastasis in nearly 5 years;
- lymphoma involvement of the central nervous system;
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 combined with rituximabThis is a single-arm trial. Patients with relapsed/refractory marginal zone lymphoma will be treated with the OR regimen. The treatment plan is as follows: Orelabrutinib 150mg oral administration once a day, Day 1-21; Rituximab 375mg/m² intravenous infusion, Day 1. Each cycle is 21 days. PET-CT evaluation will be conducted after 4 cycles. If a partial response (PR) or better is achieved, the patient will receive further treatment with the OR regimen for an additional 4 cycles before transitioning to single-agent maintenance therapy with either rituximab or obinutuzumab. If a PR or better is not achieved after 4 cycles, the patient will discontinue from the trial. | Drug | OR regimen |
Primary outcome
Objective Response Rate
Time frame: up to 8 months
Proportion of CR and PR subjects will be assessed at 8 courses
3 secondary outcomes
Progress free survival time
Time frame: up to36 months
Overall survival
Time frame: up to36 months
Adverse events profile
Time frame: Measured from start of treatment until 21 days after last dose
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 11 Jun 2024.
- Individual participant dataSharing planned: No
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.
Chen principal investigator
First Affiliated Hospital of Ningbo University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Orelabrutinib combined with rituximab in people with OR Regimen for Relapsed/Refractory Marginal Zone Lymphoma, run by Lixia Sheng at 3 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 15 inclusion and 20 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Lixia Sheng, Doctor (86-574-87085596 ext. 87085596, slx800408@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: up to 8 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 11 Jun 2024.