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Ann Arbor Stage II Follicular LymphomaPhase 2NCT06471738

Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma

A Phase 2 study testing Zanubrutinib, Rituximab and Venetoclax in people with Ann Arbor Stage II Follicular Lymphoma and Grade 1 Follicular Lymphoma, run by Chinese PLA General Hospital 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 is a single center, open label, single arm phase II clinical trial. The objective of this study is to assess the feasibility and efficacy of zanubrutinib combined with venetoclax and Rituximab in patients with previously untreated follicular lymphoma (FL) . Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zanubrutinib, Rituximab and Venetoclax
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
10 Jul 2024to 1 Jun 2027
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A diagnosis of follicular lymphoma (grades 1, 2, or 3a), untreated.
  • Stage II, III, or IV disease.
  • Able and willing to provide written informed consent and to comply with the study protocol.
  • at least one measurable disease.
  • Must be in need of therapy as evidenced by at least one of the following criteria:
  • Presence of at least one B symptom: Fever (> 38 Celsius [C]) not due to infectious etiology, or Night sweats, or Weight loss > 10% in the past 6 months;
Show all 21Show fewer
  • Fatigue due to lymphoma;
  • Splenomegaly (> 13 cm);
  • Compression syndrome (ureteral, orbital, gastrointestinal);
  • Any of the following cytopenias, due to lymphoma: Hemoglobin ≤ 10 g/dL, or Platelets ≤ 100 x 10^9/L, or Absolute neutrophil count (ANC) < 1.5 x 10^9/L;
  • Pleural or peritoneal effusion;
  • Lactate dehydrogenase (LDH) > upper limit of normal (ULN) or beta (B)2 microglobulin > ULN;
  • Other lymphoma-mediated symptoms as determined by the treating physician.
  • ECOG ≤ 2
  • ANC > 1.0 x 10^9/L (for patients without bone marrow involvement by lymphoma)
  • Platelet count > 50 x 10^9/L (for patients without bone marrow involvement by lymphoma)
  • Prothrombin time (PT)/international normal ratio (INR) < 1.5 x (upper limit of normal) ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder). When treated with warfarin or other vitamin K antagonists, then INR ≤ 3.0)
  • Serum aspartate transaminase (AST) and alanine transaminase (ALT) < 3 x ULN
  • Creatinine clearance > 30 ml/min calculated by modified Cockcroft-Gault formula
  • Bilirubin < 1.5 x ULN unless bilirubin is due to Gilbert's syndrome, documented liver involvement with lymphoma, or of non-hepatic origin, in which case bilirubin should not exceed 3 g/dL
  • Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [B-hCG]) pregnancy test at screening. Women who are pregnant or breastfeeding are ineligible for this study

Who cannot join

  • Known active central nervous system lymphoma or leptomeningeal disease
  • Follicular lymphoma with evidence of diffuse large B-cell transformation
  • Grade 3b follicular lymphoma
  • Any prior history of other malignancy besides follicular lymphoma
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
  • Patients who have undergone major surgery within 14 days
  • The researchers believe that it is not advisable for the participant to take part in this trial.

Trial locations and contacts

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

YANG LIU, MD contact

010-66937463

liuyang301blood@163.com

China1 site, 1 recruiting

  • Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital

    Beijing, 100853

    Weidong Han, 86-10-13651392893, hanwdrsw@sina.com

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of Zanubrutinib in Combination With Rituximab and Venetoclax in Previously Untreated Follicular Lymphoma: An Open Label, Phase 2 Study

This is a single center, open label, single arm phase II clinical trial. The objective of this study is to assess the feasibility and efficacy of zanubrutinib combined with venetoclax and Rituximab in patients with previously untreated follicular lymphoma (FL) .

Read the detailed description

Follicular lymphoma (FL)is the most common inert non Hodgkin's lymphoma (iNHL). Their natural courses are slow but highly variable. The standard first-line treatment of advanced FL is based on rituximab. Whether combined with chemotherapy or not, it can induce lasting remission, but it is usually incurable. Although the first-line immunochemotherapy regimen has high efficacy, it also has high toxicity. Cytotoxic chemotherapy is related to many side effects, including bone marrow suppression and immunosuppression, gastrointestinal and cardiac toxicity, neurotoxicity and the occurrence of secondary tumors. About 20% of FL patients relapse within 2 years after first-line chemotherapy. The overall prognosis of these patients is poor. This clinical trial aims to evaluate the feasibility and efficacy of free-chemotherapy regimen (zanubrutinib combined with venetoclax and Rituximab) in patients with previously untreated follicular lymphoma.

Being tested
Zanubrutinib, Rituximab, Venetoclax
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • ZanubrutinibDrug

    BTK inhibitor

  • RituximabBiological

    Monoclonal antibody to CD20

  • VenetoclaxDrug

    BCL-2 inhibitor

Study groups in NCT06471738
Study groupRoleWhat they receive
Treatment (zanubrutinib, venetoclax, rituximab)Experimentalstage I (cycles 1-3, every 4 weeks): zanubrutinib PO 160mg, BID; rituximab IV on day 1. stage II (cycles 4-9, every 4 weeks): if complete response : zanubrutinib PO 160mg, BID; rituximab IV on day 1. if no complete response : zanubrutinib PO160mg, BID; rituximab IV on day 1 and Venetoclax PO (100mg D1, 200mg D2, and 400mg D3 of cycle 4; 400mg QD).
Receives: Drug: Zanubrutinib; Biological: Rituximab; Drug: Venetoclax

What is being measured

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

  1. CR rate

    Determined by PET/CT based on Cheson, Lugano classification 2014 as assessed by the investigator. The number and percentage of subjects with a CR will be tabulated.

    Measured: Within 6 months of therapy completion

Secondary outcomes (4)

  1. Overall response rate (ORR)

    CR + partial response (PR), determined by PET/CT based on Cheson, Lugano classification 2014 as assessed by the investigator. The number and percentage of subjects with an ORR will be tabulated.

    Measured: Within 6 months of therapy completion

  2. Progression-free survival

    PFS is defined as the duration from date of treatment initiation to date of disease progression or death from any cause

    Measured: up to two years

  3. Overall survival

    PFS is defined as the duration from date of treatment initiation to date of death from any cause

    Measured: up to two years

  4. Incidence of Treatment-Emergent Adverse Events

    Incidence of subjects occuring treatment related adverse events.

    Measured: Up to 90 days after the last dose of study drugs

Timeline

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

  1. First posted24 Jun 2024
  2. Study start10 Jul 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion1 Jun 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06471738
Sponsor's protocol ID
CHN-PLAGH-BT-086
Status last verified
Jul 2026
First submitted
18 Jun 2024
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zanubrutinib, Rituximab and Venetoclax in people with Ann Arbor Stage II Follicular Lymphoma and Grade 1 Follicular Lymphoma, run by Chinese PLA General Hospital 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 21 inclusion and 7 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 20 Jul 2026. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 YANG LIU, MD (010-66937463, liuyang301blood@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CR rate (time frame: Within 6 months of therapy completion). 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 NCT06471738.

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 20 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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