BridgeMD
New treatment option for OR Regimen for Relapsed/Refractory Marginal Zone Lymphoma
Official title Clinical Study of OR for Second-line Treatment of Refractory MZL
ClinicalTrials.gov ID: NCT06134284
What this study is testing
What is Orelabrutinib combined with rituximab?
Orelabrutinib combined with rituximab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for or regimen for relapsed/refractory marginal zone lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- at least one two-dimensional measurable lymph node lesion (CT scan or MR / display maximum diameter\> 1.5cm), Or at least one two-dimensional...
- 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 how well it works above...
You likely can't join if
- The patient had been previously treated with obutinib in combination with rituximab, how well it works was assessed as being refractory, Infraciness...
- 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:
See the full eligibility criteria
Who can 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...
- 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\>...
- 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 how well it works above PR after imaging evaluation, Or disease progression after effective...
- ECOG, physical strength score 0-2;
- 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 /...
- 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...
- 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...
- 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...
- voluntarily signed written informed consent before test screening.
What rules you out
- The patient had been previously treated with obutinib in combination with rituximab, how well it works 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:
- 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...
- primary cardiomyopathy (e. g. dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, irregular cardiomyopathy);
- history of clinically significant QTc interval extension, Or people 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...
- 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 people 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...
- 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;
- people 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;
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China; Ningbo, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.