Combining two drugs for treating untreated marginal zone lymphomas
Orelabrutinib Combined With Obinutuzumab as First-line Treatment for Marginal Zone Lymphoma：a Prospective Single Arm Trial
This study is testing a new combination of two drugs to see if it can help people with untreated marginal zone lymphoma get better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | obinutuzumab, orelabrutinib, rituximab, cyclophosphamide, doxorubicin, prednisone |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06513234 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to evaluate the safety and efficacy of a combination treatment using orelabrutinib and obinutuzumab in patients with untreated marginal zone lymphoma. The study will recruit 45 patients who will receive 6 cycles of the combined treatment, followed by 18 cycles of orelabrutinib if they achieve complete or partial remission. The primary goal is to assess the complete remission rate at 12 months, providing insights into the effectiveness of this new treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed CD20-positive marginal zone lymphoma who have not received prior systemic treatment.
Not a fit: Patients with marginal zone lymphoma who have already undergone systemic treatment or have severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for patients with marginal zone lymphoma, potentially improving remission rates.
How similar studies have performed: While there have been studies on individual treatments for marginal zone lymphoma, this specific combination approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Age ≥18 years, gender unrestricted; * Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL; * MZL that has progressed, recurred, or is unsuitable for local treatment after previous local therapy (local treatments include surgery, radiotherapy, Helicobacter pylori treatment, hepatitis C treatment); * ECOG performance status score of 0-2. * Major organ functions meet the following criteria: a) Complete blood count: Absolute neutrophil count ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, absolute neutrophil count ≥1.0×10\^9/L, platelets ≥50×10\^9/L, hemoglobin ≥50g/L; b) Blood biochemistry: Total bilirubin ≤1.5 times the upper limit of normal (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. * Life expectancy ≥3 months; * Voluntarily sign a written informed consent form before the trial screening. Exclusion Criteria: * Currently or previously having other malignant tumors, unless radical treatment has been performed and there is evidence of no recurrence or metastasis within the last 5 years; * Lymphoma involving the central nervous system or transforming into a higher grade; * Having uncontrollable or significant cardiovascular diseases, including: a) New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina, myocardial infarction within 6 months before the first administration of the study drug, or arrhythmias requiring treatment at the time of screening, with a left ventricular ejection fraction (LVEF) \<50%; b) Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy); c) A history of clinically significant QTc interval prolongation, or a QTc interval \>470ms in females and \>450ms in males during the screening period; d) Subjects with symptomatic or medication-requiring coronary artery heart disease; e) Subjects with difficult-to-control hypertension (despite lifestyle improvements and the use of reasonable, tolerable, and adequate doses of one or three or more antihypertensive drugs \[including diuretics\] for more than 1 month, blood pressure is still not at the standard, or it is only effectively controlled when taking four or more antihypertensive drugs). * Active bleeding within 2 months before screening, or currently taking anticoagulant drugs, or the investigator believes there is a definite bleeding tendency; * Active infection or uncontrolled HBV (positive for HBsAg and/or HBcAb with positive HBV DNA titer), positive for HCV Ab, HIV/AIDS, or other serious infectious diseases. * Any other conditions deemed unsuitable for participation in this trial by the investigator.
Where this trial is running
Tianjin
- China Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Shuhua Yi, Dr
- Email: yishuhua@ihcams.ac.cn
- Phone: 86-22-23909106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.