Status:
NOT_YET_RECRUITING
Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A
Lead Sponsor:
Sun Yat-sen University
Conditions:
Follicular Lymphoma Grade 3A
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multicenter, phase 2, randomized trial to evaluate the efficacy and safety of obinutuzumab with CHOP versus obinutuzumab with bendamustine in treatment-naïve follicular lymphoma (Grade 3A) p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- History of allergy to any component of monoclonal antibodies or investigational drugs.
- Central nervous system involvement.
- History of previous malignant tumors.
- History of active bleeding or bleeding tendencies, or requiring anticoagulant medication.
- Requirement for potent CYP3A4 inhibitors for treatment.
- Active infection, except for tumor-related B symptoms.
- Known history of Human Immunodeficiency Virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
- 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).
- Significant organ dysfunction or uncontrolled comorbidities, such as uncontrolled hypertension, decompensated cirrhosis, uncontrolled diabetes, chronic obstructive pulmonary disease, etc.
- History of severe heart disease.
- Major surgery within 4 weeks prior to enrollment.
- Participation in other clinical trials with drug intervention within 4 weeks prior to enrollment.
- Pregnant or breastfeeding women, or planning to become pregnant during the study.
- Individuals with psychiatric disorders, history of alcohol or drug abuse, or inability to provide informed consent.
- Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2030
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT06961500
Start Date
May 1 2025
End Date
November 1 2030
Last Update
May 8 2025
Active Locations (1)
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1
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, China