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Clinical Trials in China / NCT06566807
Recruiting Phase 2

Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma

NCT06566807 · tracked via the Priya Life Science China tracker
Sponsor
Huai'an First People's Hospital
Phase
Phase 2
Started
2024-08-25
Last updated
2024-08-22

Condition(s) studied

Marginal Zone Lymphoma

Investigational drug(s) / intervention(s)

Orelabrutinib, obinutuzumab

Orelabrutinib, obinutuzumab: orelabrutinib,150mg,D1-D28 obinutuzumab,1000mg,D1、D8、D15/cycle1 D1/cycle2-6 . The patients will be treated with 6 cycles of O2 regimen. Patients with CR/PR after 6 cycles of O2 treatment will be treated with 1 year of single-agent orelabrutinib regimen.

Study summary

This is a multi-center, prospective study. The main purpose is to evaluate the efficacy and safety of Orelabrutinib combined with Obinutuzumab for previously untreated MZL.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Aged ≥18 years, gender not limited; * Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL; * MZL that has progressed, recurred, or is not suitable for local treatment after previous local treatment (local treatments include surgery, radiotherapy, Helicobacter pylori treatment, and hepatitis C treatment); * ECOG 0-2; * Indication for treatment as judged by the investigator (symptomatic, with cytopenia, at risk of end-organ damage, bulky disease, persistent progression, or patient\'s desire for treatment); * Major organ function meets 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 invasion, absolute neutrophil count ≥1.0×10\^9/L, platelets ≥50×10\^9/L, hemoglobin ≥50g/L; b) Blood biochemistry: Total bilirubin ≤1.5 ULN, AST or ALT ≤2 ULN; serum creatinine ≤1.5 ULN; serum amylase ≤ULN; c) Coagulation function: International normalized ratio (INR) ≤1.5 ULN. * Expected survival time ≥3 months; * Voluntarily sign a written informed consent form before the trial screening. Exclusion Criteria: * Currently or previously diagnosed with other malignant tumors, unless curative 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 transformation to a higher grade; * Active bleeding within 2 months prior to screening, or currently taking anticoagulant medications, or the investigator considers there to be a definite bleeding tendency; * Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening; * Active infection or uncontrolled HBV (positive for HBsAg and/or HBcAb and positive for HBV DNA titer), HCV Ab positive, HIV/AIDS, or other serious infectious diseases; * Any mental or cognitive disorder that may limit the understanding, execution, and compliance with the informed consent form and the study; * Pregnant or lactating women and women of childbearing age who are unwilling to take contraceptive measures; * Need to continuously take drugs with moderate to severe inhibitory or strong inductive effects on cytochrome P450 CYP3A; * Other conditions that the investigator considers unsuitable for participating in this trial.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University#Huai'an First People's Hospital# Huai'an Jiangsu Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06566807 on ClinicalTrials.gov ↗ ← All trials in China