A-RGEMOX in the Treatment of Early Relapsed/Refractory DLBCL

Launched by ZHEJIANG CANCER HOSPITAL · Oct 12, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new combination treatment called A-RGEMOX for patients with diffuse large B-cell lymphoma (DLBCL) who have experienced an early relapse or have not responded to previous treatments. DLBCL is the most common type of lymphoma and can be aggressive, but this study aims to find out if combining anlotinib with other medications like rituximab, gemcitabine, and oxaliplatin can help improve outcomes for patients facing these challenges.

To be eligible for the trial, participants must be at least 18 years old, have a confirmed diagnosis of DLBCL, and have either relapsed within 12 months of treatment or not responded to their first treatment. Patients should also have certain organ functions within a specified range and generally be in good health. If you decide to participate, you can expect to undergo various tests and receive the study treatment, while being closely monitored for safety and effectiveness. Please note that there are some specific conditions that would exclude someone from joining the study, so it’s important to discuss your individual situation with your healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• • Participate in the clinical study voluntarily: fully understand and be informed of the study and sign the informed consent in person; Willing to follow and be able to complete all test procedures.
• • Age≥18 years old, ECOG score ≥2 points, both male and female.
• • Histopathologically confirmed as diffuse large B-cell lymphoma, not otherwise specified; high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; high-grade B-cell lymphoma, not otherwise specified; EBV positive diffuse large B-cell lymphoma
• * Must meet one of the following conditions:
• • 1. Early relapse: response (≥PR) to first-line systemic therapy (including rituximab and anthracyclines) and disease progression within 12 months after the end of treatment;
• • 2. Refractory: first-line treatment includes rituximab and anthracyclines, and no response has been achieved with the most recent systemic treatment (≥PR).
• • At least one evaluable or measurable lesion that meets Lugano2014 criteria (evaluable lesion: PET/CT examination showing increased uptake in lymph nodes or extranodal areas (higher than liver) and PET/CT and/or CT consistent with lymphoma; Measurable lesions: nodular lesions \>15mm in length or extragendal lesions \>10mm in length with increased FDG uptake).
• * Adequate organ and bone marrow function, no serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function and immune deficiency:
• • 1. Neutrophil absolute count (ANC) ≥1.5×109/L (1500/mm3), platelet ≥75×109/L, hemoglobin ≥100g/L (if bone marrow is involved, platelet ≥50×109/L, ANC ≥1.0×109/L, hemoglobin ≥80g/L).
• • 2. Liver function: serum bilirubin ≤2.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5 times the upper limit of normal value (AST or ALT≤5 times the upper limit of normal value is allowed if liver is involved).
• • 3. Renal function: creatinine clearance ≥60 mL/min (estimated according to the Cockcroft-Gault formula).
• • 4. Coagulation function: INR≤1.5 times the upper limit of normal value; PT and APTT≤1.5 times the upper limit of normal value.
• • Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
• • Negative serum pregnancy test and effective contraceptive use from signing informed consent until 6 months after the last chemotherapy.
• • Life expectancy \> 3 months.
• Exclusion Criteria:
• • Pathological subtypes: primary central nervous system diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma.
• • Hemophagocytic syndrome at the time of diagnosis.
• • Central nervous system involvement secondary to lymphoma.
• • Participating in other clinical studies, or the first study drug is administered less than 4 weeks after the end of treatment in the previous clinical study.
• • Medical history of other active malignancy within 2 years prior to enrollment, except for the following conditions:(1) adequately treated in situ of the cervix carcinoma; (2) local basal cell carcinoma or squamous cell carcinoma of skin; (3) Pre-existing malignant disease that is under control and has undergone local radical treatment (surgical or other forms).
• • History of Human Immunodeficiency Virus (HIV) infection and/or acquired Immunodeficiency syndrome. Patients with positive hepatitis B surface antigen or hepatitis C virus antibody must be tested hepatitis B virus DNA (no more than 1000 iu/ml) and HCV RNA detection (below the detection limit). Patients with hepatitis B virus carriers, or stabilized hepatitis B with anti-virus treatment and cured hepatitis C can be included.
• • Major surgery was performed within 28 days prior to study initiation.
• • Any active infection, including bacterial, fungal or viral infections, that requires systemic antiinfection therapy within 14 days prior to treatment.
• • Accompanied with severe or uncontrolled disease, including symptomatic of congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer or A history of severe hemorrhagic diseases, such as hemophilia A, hemophilia B, von willebrand disease or blood transfusion or other medical intervention history of spontaneous bleeding.
• • History of stroke or intracranial hemorrhage within 6 months prior to first administration of the study drug.
• • History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months.
• • Patients who must take antiplatelet drugs and anticoagulants at the same time due to underlying diseases, and there is no alternative treatment plan.
• • Continuous treatment with strong CYP1A2 and CYP3A inhibitors or inducers is required. Patients were excluded if they had taken a strong CYP1A2 and CYP3A inhibitors or inducer within 7 days prior to the first administration of the study drug (or had taken these drugs for less than 5 half-lives).
• • Hypersensitivity to the experimental drug is known.
• • Patients deemed unsuitable for the study by researchers.