Combination of Orelabrutinib and Obinutuzumab in Untreated Marginal Zone Lymphomas

NCT ID: NCT06513234

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-11
• Study Completion Date: 2029-06-21

Brief Summary

This is a prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab a in untreated marginal zone lymphoma. It is planned to recruit 45 patients. The primary endpoint is the complete remission rate at 12 months.

Detailed Description

Marginal zone lymphomas (MZL) are a type of lymphoma that originates from the marginal zone tissue of the lymphoid follicles (Mucosa-associated lymphoid tissue, MALT), and include three subtypes: MALT lymphoma, nodal MZL, and splenic MZL. For patients with marginal zone lymphoma who have indications for systemic anti-tumor treatment, therapeutic options include rituximab monotherapy or more intensive immunochemotherapy regimens in combination with bendamustine, chlorambucil, CHOP regimen (cyclophosphamide, vincristine, doxorubicin, prednisone), etc.

This is a prospective, phase II, single-arm clinical study to initially explore the efficacy and safety of Orelabrutinib combined with obinutuzumab in patients with previously untreated marginal zone lymphoma. The patients will be treated with 6 cycles of OG regimen. Patients with CR/PR after 6 cycles of OG treatment will be treated with 18 cycles of single-agent orelabrutinib regimen.

Conditions

Marginal Zone Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OG

6 cycles of OG regimen. Patients with CR/PR after 6 cycles of OG treatment will be treated with 18 cycles of single-agent orelabrutinib regimen. Orelabrutinib 150mg QD

Group Type: EXPERIMENTAL

Orelabrutinib and obinutuzumab

Intervention Type: DRUG

Orelabrutinib and obinutuzumab 6cycles ;orelabrutinib 150mg

Interventions

Orelabrutinib and obinutuzumab

Orelabrutinib and obinutuzumab 6cycles ;orelabrutinib 150mg

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Shuhua Yi, Dr

Role: CONTACT

yishuhua@ihcams.ac.cn

86-22-23909106

Lugui Qiu, Dr

Role: CONTACT

qiulg@ihcams.ac.cn

86-22-23909172

Facility Contacts

Rui lv

Role: primary

ruilv@ihcams.ac.cn

+86-22-23909106

Other Identifiers

IIT2024013

Identifier Type: -

Identifier Source: org_study_id