Status:
RECRUITING
Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma
Lead Sponsor:
Huai'an First People's Hospital
Conditions:
Marginal Zone Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Marginal zone lymphoma (MZL) is a relatively common type of B-cell non-Hodgkin lymphoma (B-NHL), with an incidence rate second only to diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 10 2028
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06566807
Start Date
August 25 2024
End Date
August 10 2028
Last Update
August 22 2024
Active Locations (1)
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1
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University#Huai'an First People's Hospital#
Huai'an, Jiangsu, China, 210000