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

Launched by SUN YAT-SEN UNIVERSITY · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment combinations for patients with newly diagnosed Grade 3A follicular lymphoma, which is a type of blood cancer. The treatments being compared are obinutuzumab combined with CHOP (a standard chemotherapy regimen) versus obinutuzumab combined with bendamustine (another chemotherapy drug). The goal of the trial is to find out which combination works better and is safer for patients.

To participate in this trial, patients must be at least 18 years old and have been diagnosed with Grade 3A follicular lymphoma that is positive for a specific protein called CD20. They should not have received any prior treatment for their lymphoma and need to have measurable signs of the disease. Participants will receive regular check-ups and treatment throughout the study, and they will be monitored closely for any side effects. It's important to note that there are some criteria that would exclude individuals from participating, such as having certain health conditions or a history of allergies to specific medications. This trial is currently not recruiting participants, so interested individuals will need to wait until it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed follicular lymphoma Grades 3A, CD20 positive by immunohistochemistry.
• • 2. Meets at least one GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria.
• • 3. No prior systemic treatment for lymphoma.
• • 4. Presence of measurable lesions.
• • 5. Age ≥ 18 years, no gender restriction.
• • 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• • 7. Expected survival of \> 3 months.
• • 8. Adequate organ and bone marrow function.
• Exclusion Criteria:
• • 1. History of allergy to any component of monoclonal antibodies or investigational drugs.
• • 2. Central nervous system involvement.
• • 3. History of previous malignant tumors.
• • 4. History of active bleeding or bleeding tendencies, or requiring anticoagulant medication.
• • 5. Requirement for potent CYP3A4 inhibitors for treatment.
• • 6. Active infection, except for tumor-related B symptoms.
• • 7. Known history of Human Immunodeficiency Virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
• • 8. 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).
• • 9. Significant organ dysfunction or uncontrolled comorbidities, such as uncontrolled hypertension, decompensated cirrhosis, uncontrolled diabetes, chronic obstructive pulmonary disease, etc.
• • 10. History of severe heart disease.
• • 11. Major surgery within 4 weeks prior to enrollment.
• • 12. Participation in other clinical trials with drug intervention within 4 weeks prior to enrollment.
• • 13. Pregnant or breastfeeding women, or planning to become pregnant during the study.
• • 14. Individuals with psychiatric disorders, history of alcohol or drug abuse, or inability to provide informed consent.
• • 15. Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.