This study aims to evaluate the safety and efficacy of orelabrutinib (O) in combination with obinutuzumab (G) and short-course venetoclax (V) in patients with treatment-naïve MCL.
Inclusion Criteria:
Exclusion Criteria:
Received prior treatment for lymphoma within 2 weeks before study enrollment;
Any serious medical condition, including but not limited to:
Uncontrolled hypertension (defined as blood pressure that remains uncontrolled after at least 4 weeks of treatment with a reasonable and tolerable regimen of 3 or more antihypertensive agents [including diuretics] at adequate doses, or requiring 4 or more antihypertensive agents to achieve adequate control);
Uncontrolled congestive heart failure within 6 months prior to screening (New York Heart Association [NYHA] Class III [moderate] or Class IV [severe] cardiac disease);
Left ventricular ejection fraction (LVEF) < 50%;
Symptomatic coronary artery disease (e.g., chest tightness, chest pain, palpitations, fatigue) or coronary artery disease requiring medical therapy; ⑤Severe bradycardia (heart rate < 40 beats per minute [bpm]) with hypotension, dizziness, or syncope; patients with a history of arrhythmia should undergo cardiac evaluation;
Known active bacterial, viral, fungal, or other infection (excluding fungal infection of the nail bed), or major infection within 2 weeks prior to the first dose of study drug;
Known active hepatitis C virus (HCV) infection; or other acquired or congenital immunodeficiency disorders, including but not limited to human immunodeficiency virus (HIV) infection;
All patients with central nervous system (CNS) involvement by lymphoma;
Diagnosis of or receiving treatment for another malignancy other than lymphoma, except for the following:
①Malignancy that has been treated with curative intent and with no known active disease for ≥ 5 years prior to enrollment;
②Adequately treated basal cell carcinoma of the skin (excluding melanoma) with no evidence of disease;
③Adequately treated carcinoma in situ of the cervix with no evidence of disease;
Known hypersensitivity to any study drug;
Pregnant or breastfeeding women;
History of stroke or intracranial hemorrhage within 6 months prior to enrollment;
Requirement for anticoagulation therapy with warfarin or equivalent vitamin K antagonists;
Requirement for long-term treatment with strong cytochrome P450 3A (CYP3A) inhibitors;
Receipt of live attenuated vaccine within 4 weeks prior to enrollment.
cynthia0311@163.com+8613770698391
Induction Phase (6 cycles, 28 days per cycle): Orelabrutinib + Obinutuzumab \+ Venetoclax. Patients achieving partial response (PR) or complete response (CR) after 3 cycles will receive an additional 3 cycles of induction therapy.Patients with stable disease (SD) or progressive disease (PD) after 3 cycles will be withdrawn from the study.Patients achieving PR or CR at the end of induction will proceed to the maintenance phase (Cycles 7-24).Patients with SD or PD at the end of induction will be withdrawn from the study. Maintenance Phase (18 cycles, 28 days per cycle): Orelabrutinib + Obinutuzumab \+ Venetoclax
cynthia0311@163.com86 25 86307573
Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease
Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment
Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
Optimize Study - Orelabrutinib Combined With BR/G in Untreated Marginal Zone Lymphoma (MZL)
Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL
Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma.
Combination of Orelabrutinib and Obinutuzumab in Untreated Marginal Zone Lymphomas
Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL: A Randomized, Open Phase II Trial