Not yet recruiting NCT06961500
Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Obinutuzumab, CHOP, Bendamustine.
- Who it may be relevant to
- Registry conditions: Follicular Lymphoma Grade 3A. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Drug Obinutuzumab
1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6 - 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. - Drug Bendamustine
90 mg/m2 i.v. drip, administered on D1-2.
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: Assessed up to 5 years.]
Secondary outcome measures (5)
- Complete Response (CR) [Time frame: Up to 6 cycles (up to 24 weeks).]
- Objective Response Rate (ORR) [Time frame: Up to 6 cycles (up to 24 weeks).]
- Event-Free Survival (EFS) [Time frame: Assessed up to 5 years.]
- Overall Survival (OS) [Time frame: Assessed up to 5 years.]
- Progression of Disease within 24 months (POD24) [Time frame: 24 months.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University — Guangzhou
Identifiers
NCT: NCT06961500 · B2025-125-01