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New treatment option for Follicular Lymphoma
Official title Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma
ClinicalTrials.gov ID: NCT07126678
What this study is testing
What is zanubrutinib, bendamustine, and obinutuzumab?
zanubrutinib, bendamustine, and obinutuzumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for follicular lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study investigates a fixed-duration regimen of zanubrutinib, bendamustine, and obinutuzumab (ZBG) in the treatment of treatment-naïve patients with advanced-stage follicular lymphoma. Patients will receive combination therapy with zanubrutinib, bendamustine, and obinutuzumab over 6 cycles, with each cycle lasting 28 days.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntary participation with signed informed consent;
- Age ≥18 years and ≤75 years, regardless of gender;
- Life expectancy ≥3 months;
- ECOG performance status 0-2; patients with ECOG 3 may be enrolled only if their decline in performance status is disease-related and the investigator...
- Histologically confirmed diagnosis of grade I, II, or IIIa follicular lymphoma (FL), treatment-naïve, stage III-IV disease, and meeting treatment...
You likely can't join if
- Grade IIIb FL or transformed FL;
- Received lymphoma-directed therapy within 2 weeks prior to enrollment;
- Any severe medical condition, including but not limited to:
- Poorly controlled hypertension (defined as failure to achieve control despite lifestyle modifications and treatment with at least 3 maximally...
- Uncontrolled congestive heart failure (NYHA class 3 [moderate] or 4 [severe]) within 6 months prior to screening;
- Left ventricular ejection fraction (LVEF) \<50%;
See the full eligibility criteria
- Voluntary participation with signed informed consent;
- Age ≥18 years and ≤75 years, regardless of gender;
- Life expectancy ≥3 months;
- ECOG performance status 0-2; patients with ECOG 3 may be enrolled only if their decline in performance status is disease-related and the investigator judges they may benefit from treatment;
- Histologically confirmed diagnosis of grade I, II, or IIIa follicular lymphoma (FL), treatment-naïve, stage III-IV disease, and meeting treatment criteria (GELF criteria);
- Measurable and/or evaluable lymphoma lesions;
- Adequate bone marrow reserve: absolute neutrophil count (ANC) \>1.0×10⁹/L or platelets \>75×10⁹/L, unless cytopenia is deemed related to bone marrow infiltration by lymphoma and the investigator believes it may recover;
- Liver function: AST (SGOT), ALT (SGPT) ≤2.5×ULN (without liver involvement) or ≤5×ULN (with liver involvement); total bilirubin (TBIL) ≤ULN; serum creatinine (CRE) ≤1.5×ULN;
- Creatinine clearance ≥30 mL/min (calculated by Cockcroft-Gault formula);
- Ability to comply with study visit schedules and other protocol requirements;
- All patients of childbearing potential must agree to use effective contraception during the study and for 24 months after treatment cessation; women of childbearing potential must have a negative urine pregnancy test...
- Grade IIIb FL or transformed FL;
- Received lymphoma-directed therapy within 2 weeks prior to enrollment;
- Any severe medical condition, including but not limited to:
- Poorly controlled hypertension (defined as failure to achieve control despite lifestyle modifications and treatment with at least 3 maximally tolerated antihypertensive drugs [including diuretics] for ≥4 weeks, or...
- Uncontrolled congestive heart failure (NYHA class 3 [moderate] or 4 [severe]) within 6 months prior to screening;
- Left ventricular ejection fraction (LVEF) \<50%;
- Symptomatic coronary artery disease (e.g., chest pain, palpitations, fatigue) or requiring medication;
- Severe bradycardia (heart rate \<40 bpm), hypotension, dizziness, or syncope; patients with arrhythmia history require cardiac evaluation;
- Active bacterial, viral, fungal, or other infections (except for nail fungal infections) or major infections within 2 weeks before the first dose of study drug;
- Moderate to severe liver disease (Child-Pugh B or C);
- Active bleeding within 2 months before screening or clinically significant bleeding tendency per investigator judgment;
- Pulmonary conditions impairing function (e.g., pulmonary fibrosis, drug-induced pneumonitis) deemed intolerable by the investigator;
- Any psychiatric or cognitive impairment that may compromise understanding of informed consent, protocol compliance, or study adherence;
- Known active hepatitis C virus (HCV) infection; other acquired/congenital immunodeficiency disorders, including HIV infection;
- Central nervous system (CNS) involvement by lymphoma;
- Diagnosis or treatment for malignancies other than lymphoma, except:
- Malignancies treated with curative intent and no evidence of disease for ≥5 years before enrollment;
- Adequately treated basal cell carcinoma (excluding melanoma) with no evidence of disease;
- Adequately treated cervical carcinoma in situ with no evidence of disease;
- Hypersensitivity to any study drug;
- Pregnant or breastfeeding women;
- History of stroke or intracranial hemorrhage within 6 months before enrollment;
- Requiring anticoagulation with warfarin or equivalent vitamin K antagonists;
- Requiring chronic use of strong CYP3A inhibitors;
- Administration of live attenuated vaccines within 4 weeks before study entry.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.