Status:
RECRUITING
A-RGEMOX in the Treatment of Early Relapsed/Refractory DLBCL
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Diffuse Large B-cell Lymphoma Recurrent
Diffuse Large B Cell Lymphoma Refractory
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
As the most common subtype of lymphoma, diffuse large B-cell lymphoma (DLBCL) is an aggressive but potentially curable malignancy. However, patients with early relapse (relapse within 12 months since ...
Detailed Description
Diffuse large B-cell lymphoma (DLBCL), the most common subtype of lymphoma, accounts for about 30%-40% of non-Hodgkin's lymphomas and is highly heterogeneous in terms of clinical presentation and biol...
Eligibility Criteria
Inclusion
- 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:
- Early relapse: response (≥PR) to first-line systemic therapy (including rituximab and anthracyclines) and disease progression within 12 months after the end of treatment;
- 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:
- 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).
- 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).
- Renal function: creatinine clearance ≥60 mL/min (estimated according to the Cockcroft-Gault formula).
- 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
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT06086197
Start Date
October 1 2023
End Date
October 1 2026
Last Update
June 25 2024
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022