Zanubrutinib in Combination With Obinutuzumab (ZO) for Newly Diagnosed Follicular Lymphoma

NCT ID: NCT06553352

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2027-08-31

Brief Summary

To evaluate the efficacy and side effects of Zanubrutinib combined with Obinutuzumab (ZO) in the treatment of newly diagnosed follicular lymphoma.

Detailed Description

Zanubrutinib (Z) 160mg bid oral d1-21 Obinutuzumab (O) C1 1000mg d1,8,15 C2-C6 d1 IV, then every 8 weeks until full 20 infusions (1 year maintenance)

Conditions

Follicular Lymphoma; Newly Diagnosed

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zanubrutinib (Z) combined with Obinutuzumab (O)

Zanubrutinib (Z) 160mg bid oral d1-21 Obinutuzumab (O) C1 1000mg d1,8,15 C2-C6 d1 IV, then every 8 weeks until full 20 infusions (1 years maintenance)

Group Type: EXPERIMENTAL

Zanubrutinib combined with Obinutuzumab

Intervention Type: DRUG

Zanubrutinib combined with Obinutuzumab (ZO), a specific dose on specific days.

Interventions

Zanubrutinib combined with Obinutuzumab

Zanubrutinib combined with Obinutuzumab (ZO), a specific dose on specific days.

Intervention Type: DRUG

Other Intervention Names

Zanubrutinib combined with Obinutuzumab (ZO)

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;

Exclusion Criteria

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).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaanxi Provincial Cancer Hospital

OTHER

Sponsor Role: collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role: collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Bing, Xu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bing Xu

Role: PRINCIPAL_INVESTIGATOR

The First Aiffiliated hosptical of xiamen University

Locations

Bing Xu

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bing Xu, PhD

Role: CONTACT

xubingzhangjian@126.com

18750918842

Facility Contacts

Bing Xu

Role: primary

Other Identifiers

XMDYYYXYK-10

Identifier Type: -

Identifier Source: org_study_id