Marginal Zone Lymphoma
Conditions
Interventions
Trial Group:Orelabrutinib 150mg once daily orally, D1-D28/cycle1-24
Rituximab 375mg/m2 on D1/cycle1-12
Lenalidomide 15mg/d on D1-D21 in cycle 1, then 20mg/d on D1-D21/cycle2-12
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, male or female. 2. Histopathologically confirmed CD20-positive marginal zone lymphoma (MZL), including mucosa-associated lymphoid tissue (MALT) lymphoma, splenic MZL (SMZL), and nodal MZL (NMZL), with at least one measurable lesion (>1.5 cm in any single dimension) outside the spleen. 3. MZL that has progressed or recurred after prior local therapy, or is unsuitable for local therapy (local therapies include surgery, radiotherapy, Helicobacter pylori eradication therapy, and anti-hepatitis C therapy). 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (a score of 3 is permitted only if the investigator determines that the deterioration in performance status is primarily attributable to tumor burden). 5. Presence of a treatment indication as determined by the investigator (e.g., symptomatic disease, cytopenia, risk of end-organ damage, bulky disease, progressive disease, or patient willingness to receive treatment). 6. Adequate organ function defined by the following criteria: (1) Hematology: Absolute neutrophil count (ANC) >= 1.5*10^9/L, platelets >= 75*10^9/L, hemoglobin >= 75 g/L. In cases of bone marrow involvement, ANC >= 1.0*10^9/L, platelets >= 50*10^9/L, hemoglobin >= 50 g/L are permitted. (2) Blood biochemistry: Total bilirubin = 3 months. 8. Voluntary provision of written informed consent prior to any study-specific screening procedures.
Exclusion criteria
Exclusion criteria: 1. Current or prior history of other malignancies, unless treated with curative intent and with no evidence of recurrence or metastasis within the preceding 5 years. 2. Lymphoma involving the central nervous system or evidence of histologic transformation to a high-grade lymphoma. 3. Use of prednisone > 20 mg/day (or equivalent) for anti-tumor purposes within 7 days prior to the first dose of study drug, or use of chemotherapy, targeted therapy, radiotherapy, anti-tumor traditional Chinese medicine, or antibody-based therapy within 4 weeks. 4. Failure to recover from non-hematologic toxicities of prior anti-tumor therapy to = II congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose of study drug, or presence of arrhythmia requiring treatment at screening, left ventricular ejection fraction (LVEF) 470 ms for females or > 450 ms for males. (4) Symptomatic coronary artery disease or requiring medical therapy. (5) Uncontrolled hypertension (defined as blood pressure that remains above target despite optimized doses of at least 3 antihypertensive drugs [including a diuretic] for > 1 month, or requiring >= 4 antihypertensive drugs for adequate control). 6. Active bleeding within 2 months prior to screening, current use of anticoagulants, or a clear bleeding tendency as determined by the investigator. 7. Urine protein >= 2+ and 24-hour urine protein quantification >= 2 g/24 hours. 8. History of deep vein thrombosis or pulmonary embolism within the prior 6 months. 9. Clinically significant gastrointestinal abnormalities that may affect the ingestion, transit, or absorption of the study drug (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or history of total gastrectomy. 10. History of organ transplantation or allogeneic bone marrow transplantation. 11. Major surgery within 6 weeks prior to screening, or minor surgery within 2 weeks prior to screening. Major surgery is defined as surgery requiring general anesthesia; diagnostic endoscopy is not considered major surgery. Insertion of vascular access devices is exempt from this criterion. 12. Active infection, or uncontrolled hepatitis B virus (HBV) infection (defined as HBsAg positive and/or HBcAb positive with detectable HBV DNA), hepatitis C virus (HCV) infection (HCV Ab positive), HIV/AIDS, or other severe infectious disease. 13. Presence of pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or other conditions significantly impairing pulmonary function. 14. Prior treatment with inhibitors of Bruton's tyrosine kinase (BTK), B-cell receptor (BCR) pathway inhibitors (e.g., PI3K, Syk), or BCL-2 inhibitors. 15. Eligible and planning to undergo stem cell transplantation. 16. Any psychiatric or cognitive disorder that may limit the understanding, execution, or compliance with the informed consent form or study procedures. 17. History of drug abuse or alcohol addiction. 18. Pregnant or breastfeeding women, and female subjects of child
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Best Overall Response Rate;Time to Response;Overall Survival;Progression-Free Survival;Duration of Response;2-Year Progression-Free Survival and Overall Survival Rates;Health-Related Quality of Life; | — |
Countries
China
Contacts
Public ContactJin Fengyan
The First Hospital of Jilin University
Outcome results
None listed