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

Sun Yat-sen University

Status and phase: Not yet enrolling; Phase 2

Conditions: Follicular Lymphoma Grade 3A

Treatments: Drug: Obinutuzumab; Drug: Bendamustine; Drug: CHOP

Study type: Interventional

Funder types: Other

Identifiers

NCT06961500

B2025-125-01

Details and patient eligibility

About

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.

Enrollment: 133 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 2 patient groups

Obinutuzumab and CHOP Combination Treatment

Active Comparator group

Description:

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.

Treatment:

Drug: CHOP

Drug: Obinutuzumab

Obinutuzumab and Bendamustine Combination Treatment

Experimental group

Description:

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.

Treatment:

Drug: Bendamustine

Drug: Obinutuzumab