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

NCT06553352 | Recruiting Phase 2

• 1 other identifier: XMDYYYXYK-10
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Follicular Lymphoma; Newly Diagnosed

Outcome Measures

Primary Outcomes (1)

• CR

  Complete remission rate

  up to 1 year

Study Arms (1)

Zanubrutinib (Z) combined with Obinutuzumab (O)

EXPERIMENTAL

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)

Drug: Zanubrutinib combined with Obinutuzumab

Interventions

Zanubrutinib combined with Obinutuzumab DRUG

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

Also known as: Zanubrutinib combined with Obinutuzumab (ZO)

Zanubrutinib (Z) combined with Obinutuzumab (O)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥18 years old and gender-neutral;
• Follicular lymphoma definitively diagnosed according to the REAL/WHO classification, stage II-IV requiring treatment according to the GELF code;
• ECOG score 0-2;

You may not qualify if:

• HBV-positive serology (concealed carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) Enrollment only if HBV-DNA test is negative;
• 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);
• Informed consent (patients must sign an informed consent form for all studies).
• Medically significant CNS lymphoma or molluscum contagiosum or large cell transformation;
• HIV-positive patients and or HCV active infection (documented by HCV-RNA positive test);
• 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;
• 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;
• 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;
• Severe COPD with combined hypoxemia;
• Active bacterial, fungal, and, or viral infections not controlled by systemic therapy;
• 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;
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead
• Shanxi Provincial Cancer Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• Fujian Cancer Hospital: collaborator
• Jiangxi Provincial Cancer Hospital: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• Sun Yat-sen University: collaborator
• Huazhong University of Science and Technology: collaborator

Study Sites (1)

Bing Xu

Xiamen, Fujian, 361003, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

obinutuzumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bing Xu

  The First Aiffiliated hosptical of xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Xu, PhD

CONTACT

18750918842; xubingzhangjian@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 14, 2024
• Study Start: March 31, 2024
• Primary Completion: April 20, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 3, 2024

Record last verified: 2024-08

Locations

CN (1)