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Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A | Clinical Trials | Clareo Health

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

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)

NCT06961500•Sun Yat-sen University

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (1)

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

Guangzhou, Guangdong, China

Key Dates

Start Date

May 1, 2025

Primary Completion Date

November 1, 2030

Completion Date

November 1, 2030

Last Updated

May 8, 2025

Enrollment

133

ESTIMATED participants

Conditions

Follicular Lymphoma Grade 3A

Interventions

Obinutuzumab

DRUG

CHOP

DRUG

Bendamustine

DRUG

Contacts

Qingqing Cai

CONTACT

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