Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma：a Multicenter Prospective Single Arm Trial

PUMCH-NHL-017

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab and lenalidomide in untreated marginal zone lymphoma. The primary objective was the best complete response rate (CRR).

2024-06-01

2026-06-01

2028-06-01

Recruiting

Early phase I

45

Inclusion Criteria: * Age ≥ 18 years, either sex. * Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal). * At least 1 measurable lesion * Eligible for treatment: meets the GELF criteria, or has clinical symptoms/organ dysfunction related to the disease * Patients who are not suitable for local radiotherapy or whose condition progresses after local treatment, and those not suitable for local radiotherapy include the following situations: * Ann Arbor non-continuous Stage II or Stage III-IV non-gastric MALT and nodal MZL * SMZL (Splenic Marginal Zone Lymphoma) * Gastric MALT with Lugano Stage II2/IIE/IV * ECOG performance status (PS) score of 0-2. * Expected survival time is ≥3 months * Sign the Informed consent Exclusion Criteria: * Currently has other malignant tumors; * Lymphoma involving the central nervous system * Allergic to any of the study drugs; * Active infection or uncontrolled HBV infection (DNA\>105/ml), HIV/AIDS, or other severe infectious diseases; * Pregnant or lactating women and women of childbearing age who are unwilling to use contraception; * Any other conditions deemed unsuitable for participation in this trial by the investigator.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}

2024-06-12