Comparing two drug combinations for newly diagnosed follicular lymphoma grade 3A
Compares obinutuzumab with CHOP against obinutuzumab with bendamustine in adults newly diagnosed with follicular lymphoma.
Plain-language title generated from the registry record
Registry title: Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 2
Where in China
- Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,Guangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Yat-sen University
- Trial code
- NCT06961500
- Record updated
- 8 May 2025
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: History of allergy to any component of monoclonal antibodies or investigational drugs; Requirement for potent CYP3A4 inhibitors for treatment; 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); Major surgery within 4 weeks prior to enrollment; Participation in other clinical trials with drug intervention within 4 weeks prior to enrollment; History of previous malignant tumors; History of active bleeding or bleeding tendencies, or requiring anticoagulant medication; Active infection, except for tumor-related B symptoms; Known history of Human Immunodeficiency Virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS); Significant organ dysfunction or uncontrolled comorbidities, such as uncontrolled hypertension, decompensated cirrhosis, uncontrolled diabetes, chronic obstructive pulmonary disease, etc; History of severe heart disease; Individuals with psychiatric disorders, history of alcohol or drug abuse, or inability to provide informed consent; Central nervous system involvement; Pregnant or breastfeeding women, or planning to become pregnant during the study; Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.