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Recruiting Phase 2

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

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About this study

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.

Condition
Marginal Zone Lymphoma
Tested
Orelabrutinib, obinutuzumab
Sponsor
Huai'an First People's Hospital

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Study condition: Marginal Zone Lymphoma
  • 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 9

  • 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.

Where

1 site, 1 recruiting

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

Huai'an, Jiangsu, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.