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

NCT06961500 | Not Yet Recruiting Phase 2

• 1 other identifier: B2025-125-01
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  From study entry to the first documented disease progression or death from any cause.

  Assessed up to 5 years.

Secondary Outcomes (5)

• Complete Response (CR)

  Up to 6 cycles (up to 24 weeks).

• Objective Response Rate (ORR)

  Up to 6 cycles (up to 24 weeks).

• Event-Free Survival (EFS)

  Assessed up to 5 years.

• Overall Survival (OS)

  Assessed up to 5 years.

• Progression of Disease within 24 months (POD24)

  24 months.

Study Arms (2)

Obinutuzumab and CHOP Combination Treatment

ACTIVE COMPARATOR

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.

Drug: Obinutuzumab; Drug: CHOP

Obinutuzumab and Bendamustine Combination Treatment

EXPERIMENTAL

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.

Drug: Obinutuzumab; Drug: Bendamustine

Interventions

Obinutuzumab DRUG

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

Obinutuzumab and Bendamustine Combination Treatment; Obinutuzumab and CHOP Combination Treatment

CHOP 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 CHOP Combination Treatment

Bendamustine DRUG

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

Obinutuzumab and Bendamustine Combination Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

obinutuzumab; Bendamustine Hydrochloride

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Qingqing Cai

CONTACT

0086-020-87342823; caiqq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: May 8, 2025

Record last verified: 2025-04

Locations

CN (1)