Clinical trial NCT06961500: Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A
Official title: A Multicenter, Phase 2, Randomized Trial of Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A (FL)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Follicular Lymphoma Grade 3A
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) patients.


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.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Assessed up to 5 years.
Secondary outcomes:
measure: Complete Response (CR)
timeFrame: Up to 6 cycles (up to 24 weeks).
measure: Objective Response Rate (ORR)
timeFrame: Up to 6 cycles (up to 24 weeks).
measure: Event-Free Survival (EFS)
timeFrame: Assessed up to 5 years.
measure: Overall Survival (OS)
timeFrame: Assessed up to 5 years.
measure: Progression of Disease within 24 months (POD24)
timeFrame: 24 months.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
state: Guangdong
Study officials:
References: