Marginal zone cell lymphoma
Conditions
Interventions
Treatment group:Orelabrutinib, rituximab, and lenalidomide (OR2 regimen)
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 and above, regardless of gender; 2. Histopathologically confirmed CD20-positive marginal zone lymphoma, including MALT, SMZL, and NMZL, with at least one measurable lesion (longest diameter >=1.5 cm) outside the spleen; 3. MZL with disease progression, recurrence after prior local treatment, or unsuitable for local therapy (local treatments include surgery, radiotherapy, anti–Helicobacter pylori therapy, and anti–hepatitis C therapy); 4. ECOG performance status score 0–2; 5. Treatment indication as judged by the investigator (presence of symptoms, cytopenia, risk of end-organ damage, bulky disease, persistent progression, or patient desire for treatment); 6. Adequate organ function meeting the following criteria: (1) Hematology: Absolute neutrophil count (ANC) >=1.5×10^9/L, platelets >=75×10^9/L, hemoglobin >=75 g/L; if accompanied by bone marrow involvement: ANC >=1.0×110^9/L, platelets >=50×10^9/L, hemoglobin >=50 g/L; (2)Blood biochemistry: Total bilirubin =3 months; 8. Voluntarily signed written informed consent before trial screening.
Exclusion criteria
Exclusion criteria: 1. Currently or previously diagnosed with other malignancies, except those cured with radical treatment and without evidence of recurrence or metastasis within the past 5 years. 2. Central nervous system involvement or transformation to a higher-grade lymphoma. 3. Non-hematological toxicities from prior anti-tumor therapies have not recovered to =1 month of lifestyle modifications combined with >=3 tolerable and maximally dosed antihypertensive drugs, including diuretics, or requires>=4 antihypertensive drugs for effective management). 5. Need for long-term anticoagulation therapy with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon). Patients who have used warfarin or equivalent vitamin K antagonists within 30 days before the first dose of the study drug are ineligible. 6. Active or uncontrolled infections, including uncontrolled HBV (HBsAg-positive and/or HBcAb-positive with detectable HBV DNA), HCV Ab-positive, HIV/AIDS, or other severe infectious diseases. 7. Prior treatment with BTK inhibitors, BCR pathway inhibitors (e.g., PI3K, Syk inhibitors), or BCL-2 inhibitors. 8. Any psychiatric or cognitive disorders that may limit the understanding, execution of informed consent, or compliance with the study. 9. Pregnant or breastfeeding women, and subjects of childbearing potential unwilling to use contraception. 10. Any other conditions deemed by the investigator to be unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate;Best Overall Response Rate;Progression free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactZhen Cai
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed