Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A

Korábbi kezelés

• History of allergy to any component of monoclonal antibodies or investigational drugs.
• Requirement for potent CYP3A4 inhibitors for treatment.
• Hepatitis C virus (HCV) antibody positive with HCV RNA quantitative test result exceeding the detection limit; Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive, with Hepatitis B virus DNA quantitative test result exceeding the detection limit (for patients with HBsAg or HBcAb positive status, regardless of HBV-DNA detection, oral entecavir or other antiviral therapy must be initiated prior to enrollment and continued according to the physician's instructions during the trial).
• Major surgery within 4 weeks prior to enrollment.
• Participation in other clinical trials with drug intervention within 4 weeks prior to enrollment.

Más betegség

• History of previous malignant tumors.
• History of active bleeding or bleeding tendencies, or requiring anticoagulant medication.
• Active infection, except for tumor-related B symptoms.
• Known history of Human Immunodeficiency Virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
• Significant organ dysfunction or uncontrolled comorbidities, such as uncontrolled hypertension, decompensated cirrhosis, uncontrolled diabetes, chronic obstructive pulmonary disease, etc.
• History of severe heart disease.
• Individuals with psychiatric disorders, history of alcohol or drug abuse, or inability to provide informed consent.

Egyéb

• Central nervous system involvement.
• Pregnant or breastfeeding women, or planning to become pregnant during the study.
• Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.

• Histologically confirmed follicular lymphoma Grades 3A, CD20 positive by immunohistochemistry.
• Meets at least one GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria.
• No prior systemic treatment for lymphoma.
• Presence of measurable lesions.
• Age ≥ 18 years, no gender restriction.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Expected survival of \> 3 months.
• Adequate organ and bone marrow function.