Actively Recruiting
A-RGEMOX in the Treatment of Early Relapsed/Refractory DLBCL
Led by Zhejiang Cancer Hospital · Updated on 2024-06-25
41
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 diagnosis or the end of first-line treatment, ER) or primary refractory had an even worse prognosis. Thus, the investigators plan to evaluate the efficacy and safety of anlotinib combined with rituximab, gemcitabine, oxaliplatin (A-RGEMOX) in the treatment of early relapsed/refractory diffuse large B-cell lymphoma.
CONDITIONS
Official Title
A-RGEMOX in the Treatment of Early Relapsed/Refractory DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with an ECOG score of 2 or less
- Histopathologically confirmed diffuse large B-cell lymphoma or related high-grade B-cell lymphoma
- Early relapse (disease progression within 12 months after first-line treatment) or refractory disease with no response to the most recent systemic treatment
- At least one evaluable or measurable lesion according to Lugano2014 criteria
- Adequate organ and bone marrow function with specified blood counts and liver, kidney, and coagulation parameters
- Left ventricular ejection fraction of 50% or higher
- Negative pregnancy test and effective contraception use during study and for 6 months after last chemotherapy
- Life expectancy greater than 3 months
- Voluntary participation with informed consent and ability to complete all test procedures
You will not qualify if you...
- Primary central nervous system diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma
- Hemophagocytic syndrome at diagnosis
- Central nervous system involvement secondary to lymphoma
- Participation in other clinical studies or recent administration of study drugs within 4 weeks
- Active malignancy within 2 years except for certain treated cancers
- History of HIV infection or AIDS
- Positive hepatitis B surface antigen or hepatitis C antibody without controlled infection
- Major surgery within 28 days prior to study start
- Active infections requiring systemic therapy within 14 days prior to treatment
- Severe or uncontrolled diseases including symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, or active peptic ulcer
- History of severe bleeding disorders or spontaneous bleeding requiring intervention
- Stroke or intracranial hemorrhage within 6 months prior to study drug administration
- Deep vein thrombosis or pulmonary embolism within 12 months prior to study drug administration
- Need for simultaneous antiplatelet and anticoagulant therapy without alternatives
- Continuous treatment with strong CYP1A2 or CYP3A inhibitors or inducers within 7 days before study drug
- Known hypersensitivity to study drugs
- Deemed unsuitable for the study by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
X
Xi Chen
CONTACT
H
Haiyan Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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