Combination of Orelabrutinib and Obinutuzumab in Untreated Marginal Zone Lymphomas

Trial Title: Combination of Orelabrutinib and Obinutuzumab in Untreated Marginal Zone Lymphomas

NCT ID: NCT06513234

Condition: Marginal Zone Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Obinutuzumab

Conditions: Keywords:
Marginal Zone Lymphomas
orelabrutinib
obinutuzumab

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Orelabrutinib and obinutuzumab
Description: Orelabrutinib and obinutuzumab 6cycles ;orelabrutinib 150mg
Arm group label: OG

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

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

Address:
City: Tianjin
Zip: 300020
Country: China

Status: Recruiting

Contact:
Last name: Rui lv

Phone: +86-22-23909106
Email: ruilv@ihcams.ac.cn

Start date: July 11, 2024

Completion date: June 21, 2029

Lead sponsor:
Agency: Institute of Hematology & Blood Diseases Hospital, China
Agency class: Other

Source: Institute of Hematology & Blood Diseases Hospital, China

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06513234