NCT06961500Not yet recruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 8 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 133 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 Nov 2030
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Follicular lymphoma
- NCT number
- NCT06961500
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 133
- From 1 May 2025 to the primary completion date, 1 Nov 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University, Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.