Zanubrutinib and G-CHOP in Untreated Intermediate-high Risk Follicular Lymphoma

NCT ID: NCT06474481

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2029-12-31

Brief Summary

:This is a an open-label, single-arm study to evaluate the efficacy and safety of zanubrutinib and G-CHOP in untreated Intermediate-high risk Follicular Lymphoma patients.

Conditions

FL

Study Design

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

Study Groups

Treatment arm

Induction: Zanubrutinib and G-CHOP 4-6cycles

Maintenance: Zanubrutinib and Obinutuzumab 1 year

Group Type: EXPERIMENTAL

Zanubrutinib

Intervention Type: DRUG

Zanubrutinib, 160mg PO BID.on days 1-28 Induction treatment: 4-6cycles ; Maintenance: 1 year;

Obinutuzumab

Intervention Type: DRUG

Induction treatment: Obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-4/6); for 4-6 cycles, 1 cycle = 28 days Maintenance: Obinutuzumab (G), 1000mg, IV, every 2 months for 1 year;

Prednisone

Intervention Type: DRUG

Prednisone (P), 100 mg, PO, D2-6；for 4-6 cycles for CHOP treatment , 1 cycle = 28 days

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide (C), 750 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days

Vincristine

Intervention Type: DRUG

Vincristine (O), 1.4 mg/m2 (maximum 2 mg), IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days

Doxorubicin

Intervention Type: DRUG

Doxorubicin (H), 50 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment ，1 cycle = 28 days

Interventions

Zanubrutinib

Zanubrutinib, 160mg PO BID.on days 1-28 Induction treatment: 4-6cycles ; Maintenance: 1 year;

Intervention Type: DRUG

Obinutuzumab

Induction treatment: Obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-4/6); for 4-6 cycles, 1 cycle = 28 days Maintenance: Obinutuzumab (G), 1000mg, IV, every 2 months for 1 year;

Intervention Type: DRUG

Prednisone

Prednisone (P), 100 mg, PO, D2-6；for 4-6 cycles for CHOP treatment , 1 cycle = 28 days

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide (C), 750 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days

Intervention Type: DRUG

Vincristine

Vincristine (O), 1.4 mg/m2 (maximum 2 mg), IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days

Intervention Type: DRUG

Doxorubicin

Doxorubicin (H), 50 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment ，1 cycle = 28 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed CD20 positive (+) follicular lymphoma, grade 1, 2, or 3a

2. Have had no prior systemic treatment for lymphoma

3. Meeting Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria for initiation of treatment

4. 18-75 years old.

5. ECOG Performance Status of 0-2 within 10 days prior to registration.

6. Stage II, III, or IV by Ann Arbor staging system.

7. defined as Intermediate-high risk by the follicular lymphoma international prognostic index (FLIPI) 1 or FLIPI 2.

8. Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.

• Hematological: WBC≥3.5×109/L, Platelets ≥ 75×109/L,Absolute Neutrophil Count (ANC) ≥ 1.0×109/L，Hemoglobin (Hgb) ≥ 80 g/L
• Renal:Calculated creatinine clearance ≥ 50 mL/min
• Hepatic:Bilirubin ≤ 1.5 × upper limit of normal (ULN), AST/ALT ≤ 2.5×ULN

9. Females of childbearing potential must be willing to abstain from vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study and for 6 months after the last dose of study drug(s). Males able to father a child must be willing to abstain from vaginal intercourse or to use an effective method(s) of contraception from initiation of treatment, during the study and for 3 months after the last dose of study drug(s). See the protocol.

10. Life expectancy ≥6 months

11. Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study

Exclusion Criteria

1. Known active central nervous system lymphoma or leptomeningeal disease

2. Evidence of diffuse large B-cell transformation

3. Grade 3b FL

4. Concurrent malignancy or malignancy within the last 3 years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ) whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial

5. Known history of human immunodeficiency virus (HIV), or active hepatitis C Virus, or active hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed John Cunningham (JC) virus infection

6. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association functional classification. Or left ventricular ejection fraction <50%;

7. Neuropathy ≥grade 2

8. Known history of human immunodeficiency virus (HIV), or active hepatitis C Virus, or active hepatitis B Virus infection, or any uncontrolled active significant infection

9. Known pneumonia associated with idiopathic pulmonary fibrosis, machine (for example, occlusive bronchiolitis), history of drug induced pneumonia, or screening during the chest computed tomography (CT) showed active pneumonia

10. Have serious neurological or psychiatric history, can't normal study, including dementia, epilepsy, severe depression and mania

11. Patients who were deemed by the investigator to be ineligible for enrollment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Huilai Zhang, MD,PhD

Role: CONTACT

info@tjmuch.com

0086-22-23359337

Other Identifiers

TN-FL001

Identifier Type: -

Identifier Source: org_study_id