Combining Zanubrutinib and Obinutuzumab for Treating Newly Diagnosed Follicular Lymphoma

An Open, Single-Arm Clinical Study of Zanubrutinib in Combination With Obinutuzumab (ZO) for Newly Diagnosed Follicular Lymphoma (FL)

This study is testing a new combination of two medications, Zanubrutinib and Obinutuzumab, to see if they can help people with newly diagnosed follicular lymphoma feel better and stay healthy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Xiamen University (other)
• Drugs / interventions: zebrutinib, Zerbutinib, chemotherapy, Obinutuzumab, Zanubrutinib
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT06553352 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of a combination treatment using Zanubrutinib and Obinutuzumab for patients with newly diagnosed follicular lymphoma. Participants will receive Zanubrutinib orally for 21 days alongside Obinutuzumab administered intravenously over several cycles, followed by maintenance therapy. The study aims to assess treatment outcomes and monitor any side effects experienced by the patients throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of follicular lymphoma requiring treatment.

Not a fit: Patients with early-stage follicular lymphoma who do not require immediate treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with newly diagnosed follicular lymphoma.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating follicular lymphoma, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age: ≥18 years old and gender-neutral;
2. Follicular lymphoma definitively diagnosed according to the REAL/WHO classification, stage II-IV requiring treatment according to the GELF code;
3. ECOG score 0-2;
4. Lymphoma efficacy evaluation criteria using Lugano 2014 Lymphoma must have at least one measurable or evaluable lesion: signed informed consent, subjects recruited based on inclusion and exclusion criteria, etc History taking and pre-treatment baseline examination and registration on case report form (CRF) ZO regimen of chemotherapy for 6 cycles, followed by zebrutinib monotherapy orally for 6 months, with observation of toxicities Follow-up assessment (including) Follow-up evaluation (including safety) \<Blood, biochemistry, B2-MG, neck, chest and abdomen CT plain + enhanced, questionnaire\> Follow-up evaluation (including safety) \<Blood, biochemistry, B2-MG, neck, chest and abdomen CT plain + enhanced, questionnaire, once every three months\> 1. Zerbutinib maintenance treatment for 12 months for PR and above 2. Second-line treatment for the rest of the patients (recommended by NCCN guidelines) NCCN guideline recommendation) Assessment of efficacy i.e. PET/CT with evaluable lesions; CT or MR evaluation of intranodal lesions with a long diameter \>1.5cm, short diameter \>1.0cm or extranodal lesions with a long diameter \>1.0cm;
5. HBV-positive serology (concealed carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) Enrollment only if HBV-DNA test is negative;
6. Normal major organ function: liver function serum bilirubin ≤ 2.0 × ULN , serum ALT and AST ≤ 2.5 × ULN, renal function: serum Cr ≤ 2.0 × ULN; (unless due to lymphoma);
7. Informed consent (patients must sign an informed consent form for all studies).

Exclusion Criteria:

1. Medically significant CNS lymphoma or molluscum contagiosum or large cell transformation;
2. HIV-positive patients and or HCV active infection (documented by HCV-RNA positive test);
3. Patients should not have active or uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia Patients should not have transfusion-dependent thrombocytopenia or bleeding disorders Patients should not have autoimmune disorders associated with the study drug;
4. Known bleeding disorders (e.g., vascular hemophilia or hemophilia) in combination with warfarin or other vitamin K antagonists require treatment with a potent cytochrome P450 (CYP) 3A inhibitor;
5. Patients with acute coronary syndrome within 6 months prior to study entry must not have had a stroke or intracranial hemorrhage within the past 6 months Prior Surgery: no major surgery within 28 days prior to enrollment or minor surgery within 7 days prior to enrollment; examples of minor surgery include dental procedures, venous access device insertion, skin biopsies, or joint aspirations; procedures may be major or minor at the discretion of the treating physician;
6. Severe COPD with combined hypoxemia;
7. Active bacterial, fungal, and, or viral infections not controlled by systemic therapy;
8. In addition to cured basal cell carcinoma of the skin or cervical cancer in situ or early prostate cancer that does not require systemic therapy, or early breast cancer that requires surgery alone. Other malignant tumors within the last 2 years or concurrently;
9. Pregnancy and Lactation: Female patients must have a negative serum pregnancy test within 72 hours prior to initiation of regimen therapy and use effective contraception during regimen therapy and for at least 12 weeks after completion of the study.

Where this trial is running

Xiamen, Fujian

• Bing Xu — Xiamen, Fujian, China (RECRUITING)

Study contacts

• Principal investigator: Bing Xu — The First Aiffiliated hosptical of xiamen University
• Study coordinator: Bing Xu, PhD

Conditions: Follicular Lymphoma, Newly Diagnosed