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

NCT ID: NCT06961500

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2030-11-01

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.

Conditions

Follicular Lymphoma Grade 3A

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Obinutuzumab and CHOP Combination Treatment

Obinutuzumab: 1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6.

CHOP: a) Cyclophosphamide: 750 mg/m2 i.v. drip, administered on D1; b) Doxorubicin: 50 mg/m2 i.v. drip (or Epirubicin: 70mg/m2 i.v. drip), administered on D1; c) Vincristine: 1.4 mg/m2 i.v., administered on D1; d) Prednisone: 100mg/d po, administered on D1-5.

Each cycle lasts 21 days, up to 6 cycles are administered. Then add 2 cycles of obinutuzumab monotherapy.

Group Type: ACTIVE_COMPARATOR

Obinutuzumab

Intervention Type: DRUG

1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6

CHOP

Intervention Type: DRUG

a) Cyclophosphamide: 750 mg/m2 i.v. drip, administered on D1; b) Doxorubicin: 50 mg/m2 i.v. drip (or Epirubicin: 70mg/m2 i.v. drip), administered on D1; c) Vincristine: 1.4 mg/m2 i.v., administered on D1; d) Prednisone: 100mg/d po, administered on D1-5.

Obinutuzumab and Bendamustine Combination Treatment

Obinutuzumab: 1000mg i.v., administered on D1/8/15 of C1, and D1 of C2-6. Bendamustine: 90 mg/m2 i.v. drip, administered on D1-2. Each cycle lasts 28 days, up to 6 cycles are administered.

Group Type: EXPERIMENTAL

Obinutuzumab

Intervention Type: DRUG

1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6

Bendamustine

Intervention Type: DRUG

90 mg/m2 i.v. drip, administered on D1-2.

Interventions

Obinutuzumab

1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6

Intervention Type: DRUG

CHOP

a) Cyclophosphamide: 750 mg/m2 i.v. drip, administered on D1; b) Doxorubicin: 50 mg/m2 i.v. drip (or Epirubicin: 70mg/m2 i.v. drip), administered on D1; c) Vincristine: 1.4 mg/m2 i.v., administered on D1; d) Prednisone: 100mg/d po, administered on D1-5.

Intervention Type: DRUG

Bendamustine

90 mg/m2 i.v. drip, administered on D1-2.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Qingqing Cai

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Qingqing Cai

Role: CONTACT

caiqq@sysucc.org.cn

0086-020-87342823

Facility Contacts

Qingqing Cai

Role: primary

caiqq@sysucc.org.cn

02087342823

Other Identifiers

B2025-125-01

Identifier Type: -

Identifier Source: org_study_id