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Follicular LymphomaNCT07126678

Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma

A study testing zanubrutinib, bendamustine, and obinutuzumab in people with Follicular Lymphoma and Treatment Naive, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Follicular Lymphoma, Treatment Naive
What is being tested?
zanubrutinib, bendamustine, and obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
15 Jul 2025to 30 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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 before treatment initiation.

Who cannot join

  • 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 requiring ≥4 antihypertensive drugs for adequate control);
  • Uncontrolled congestive heart failure (NYHA class 3 [moderate] or 4 [severe]) within 6 months prior to screening;
  • Left ventricular ejection fraction (LVEF) <50%;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jianyong Li Li contact

lijianyonglm@126.com

China1 site, 1 recruiting
  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210000

    Yi Xia, 13770698391, cynthia0311@163.com

    Recruiting

Other trials in China

About this study

Official title: Prospective Exploratory Study of Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma

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. The specific dosing schedule is as follows: Bendamustine 70 mg/m²: administered intravenously on Days 2-3 of Cycle 1, and on Days 1-2 of Cycles 2-6. Obinutuzumab 1000 mg: administered intravenously on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6 (every 28-day cycle). Zanubrutinib 160 mg orally twice daily (bid), continuously throughout Cycles 1-6.

Read more

Treatment is discontinued after 6 cycles, with no subsequent maintenance therapy.

Primary endpoint is 2-year PFS. Secondary endpoints include: CR rate after 6 cycles, ORR after 3 and 6 cycles MRD-negative rate after 3 and 6 cycles, OS, safety and tolerability.

Being tested
zanubrutinib, bendamustine, and obinutuzumab
Keywords
Follicular lymphoma, fixed-duration, zanubrutinib, ZBG, Treatment Naive
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • zanubrutinib, bendamustine, and obinutuzumabDrug

    Patients will receive combination therapy with zanubrutinib, bendamustine, and obinutuzumab over 6 cycles, with each cycle lasting 28 days. The specific dosing schedule is as follows: Bendamustine 70 mg/m²: administered intravenously on Days 2-3 of Cycle 1, and on Days 1-2 of Cycles 2-6. Obinutuzumab 1000 mg: administered intravenously on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6 (every 28-day cycle). Zanubrutinib 160 mg orally twice daily (bid), continuously throughout Cycles 1-6.

    Treatment is discontinued after 6 cycles, with no subsequent maintenance therapy.

Study groups in NCT07126678
Study groupRoleWhat they receive
ZBGExperimentalNot described
Receives: Drug: zanubrutinib, bendamustine, and obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year PFS

    2-year progression-free survival (PFS)

    Measured: 2 year

Secondary outcomes (5)
  1. CR Rate

    complete remission rate

    Measured: At the end of Cycle 6 (each cycle is 28 days)

  2. ORR

    objective remission rate

    Measured: At the end of Cycle 3 and 6 (each cycle is 28 days)

  3. MRD

    minimal residue rate

    Measured: At the end of Cycle 6 (each cycle is 28 days)

  4. OS

    Overall survival

    Measured: From date of randomization until the date of death from any cause, assessed up to 100 months

  5. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE

    • Adverse events and serious adverse events
    • Treatment-related adverse events leading to dose adjustments, dose interruptions, delays, and/or study drug discontinuation

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2025
  2. Study start15 Jul 2025
  3. Primary completion15 Jul 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07126678
Sponsor's protocol ID
FL-ZBG-01
Status last verified
Jul 2025
First submitted
21 Jul 2025
Last updated
17 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Serna A, Navarro V, Iacoboni G, Lopez L, Sancho JM, Gonzalez-Barca E, Lopez-Garcia A, Cordoba R, Saez A, Jimenez-Ubieto A, Ferrero A, Garcia T, Sanchez A, Garcia C, Bosch M, Cabirta A, Jimenez M, Marin-Niebla A, Bosch F, Abrisqueta P. Rituximab maintenance after bendamustine-based treatment for follicular lymphoma and mantle cell lymphoma may exert a negative influence on SARS-CoV-2 infection outcomes. Haematologica. 2025 Jan 1;110(1):173-178. doi: 10.3324/haematol.2024.285219. No abstract available.

    PubMed 38988269
  • Fowler NH, Nastoupil L, De Vos S, Knapp M, Flinn IW, Chen R, Advani RH, Bhatia S, Martin P, Mena R, Davis RE, Neelapu SS, Eckert K, Ping J, Co M, Beaupre DM, Neuenburg JK, Palomba ML. The combination of ibrutinib and rituximab demonstrates activity in first-line follicular lymphoma. Br J Haematol. 2020 May;189(4):650-660. doi: 10.1111/bjh.16424. Epub 2020 Mar 16.

    PubMed 32180219
  • Zinzani PL, Mayer J, Flowers CR, Bijou F, De Oliveira AC, Song Y, Zhang Q, Merli M, Bouabdallah K, Ganly P, Zhang H, Johnson R, Martin Garcia-Sancho A, Provencio Pulla M, Trneny M, Yuen S, Tilly H, Kingsley E, Tumyan G, Assouline SE, Auer R, Ivanova E, Kim P, Huang S, Delarue R, Trotman J. ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma. J Clin Oncol. 2023 Nov 20;41(33):5107-5117. doi: 10.1200/JCO.23.00775. Epub 2023 Jul 28.

    PubMed 37506346
  • Zinzani PL, Munoz J, Trotman J. Current and future therapies for follicular lymphoma. Exp Hematol Oncol. 2024 Aug 22;13(1):87. doi: 10.1186/s40164-024-00551-1.

    PubMed 39175100
  • Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Daguindau N, Le Gouill S, Pica GM, Martin Garcia-Sancho A, Lopez-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, Andre M, Zachee P, Sehn LH, Tobinai K, Cartron G, Liu D, Wang J, Xerri L, Salles GA; RELEVANCE Trial Investigators. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018 Sep 6;379(10):934-947. doi: 10.1056/NEJMoa1805104.

    PubMed 30184451
  • Pott C, Jurinovic V, Trotman J, Kehden B, Unterhalt M, Herold M, Jagt RV, Janssens A, Kneba M, Mayer J, Young M, Schmidt C, Knapp A, Nielsen T, Brown H, Spielewoy N, Harbron C, Bottos A, Mundt K, Marcus R, Hiddemann W, Hoster E. Minimal Residual Disease Status Predicts Outcome in Patients With Previously Untreated Follicular Lymphoma: A Prospective Analysis of the Phase III GALLIUM Study. J Clin Oncol. 2024 Feb 10;42(5):550-561. doi: 10.1200/JCO.23.00838. Epub 2023 Dec 14.

    PubMed 38096461
  • Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, Phillips E, Sangha R, Schlag R, Seymour JF, Townsend W, Trneny M, Wenger M, Fingerle-Rowson G, Rufibach K, Moore T, Herold M, Hiddemann W. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017 Oct 5;377(14):1331-1344. doi: 10.1056/NEJMoa1614598.

    PubMed 28976863
  • Casulo C, Byrtek M, Dawson KL, Zhou X, Farber CM, Flowers CR, Hainsworth JD, Maurer MJ, Cerhan JR, Link BK, Zelenetz AD, Friedberg JW. Early Relapse of Follicular Lymphoma After Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Defines Patients at High Risk for Death: An Analysis From the National LymphoCare Study. J Clin Oncol. 2015 Aug 10;33(23):2516-22. doi: 10.1200/JCO.2014.59.7534. Epub 2015 Jun 29.

    PubMed 26124482
  • Freedman A, Jacobsen E. Follicular lymphoma: 2020 update on diagnosis and management. Am J Hematol. 2020 Mar;95(3):316-327. doi: 10.1002/ajh.25696. Epub 2019 Dec 22.

    PubMed 31814159

Questions about this trial

What is this clinical trial studying?

A study testing zanubrutinib, bendamustine, and obinutuzumab in people with Follicular Lymphoma and Treatment Naive, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yi Xia (+86 25 68307573, cynthia0311@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year PFS (time frame: 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07126678, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.

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