RecruitingPhase 2NCT06566807
Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma
Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma: A Phase 2, Single-Arm, Prospective, Multicenter Clinical Study
Sponsor
Huai'an First People's Hospital
Enrollment
51 participants
Start Date
Aug 25, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria9
- 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.
Interventions
DRUGOrelabrutinib, 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06566807
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