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

NCT06474481 | Not Yet Recruiting Phase 2

• 1 other identifier: TN-FL001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

Zanubrutinib; Intermediate-high risk Follicular Lymphoma; G-CHOP

Outcome Measures

Primary Outcomes (1)

• CR (complete response) rate after induction (4 or 6 Cycles) by investigator (INV)

  Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria

  From enrollment to the end of treatment at cycle 4 or 6 (each cycle is 28 days)

Secondary Outcomes (3)

• Objective Response rate after induction by investigator (INV)

  From enrollment to the end of end of treatment at cycle 4 or 6 (each cycle is 28 days)

• Overall survival (OS)

  From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years

• Progression free survival (PFS)

  From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years

Study Arms (1)

Treatment arm

EXPERIMENTAL

Induction: Zanubrutinib and G-CHOP 4-6cycles Maintenance: Zanubrutinib and Obinutuzumab 1 year

Drug: Zanubrutinib; Drug: Obinutuzumab; Drug: Prednisone; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin

Interventions

Zanubrutinib DRUG

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

Treatment arm

Obinutuzumab 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;

Treatment arm

Prednisone DRUG

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

Treatment arm

Cyclophosphamide DRUG

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

Treatment arm

Vincristine DRUG

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

Treatment arm

Doxorubicin DRUG

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

Treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed CD20 positive (+) follicular lymphoma, grade 1, 2, or 3a
• Have had no prior systemic treatment for lymphoma
• Meeting Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria for initiation of treatment
• years old.
• ECOG Performance Status of 0-2 within 10 days prior to registration.
• Stage II, III, or IV by Ann Arbor staging system.
• defined as Intermediate-high risk by the follicular lymphoma international prognostic index (FLIPI) 1 or FLIPI 2.
• 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
• 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.
• Life expectancy ≥6 months
• 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

You may not qualify if:

• Known active central nervous system lymphoma or leptomeningeal disease
• Evidence of diffuse large B-cell transformation
• Grade 3b FL
• 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
• 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
• 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%;
• Neuropathy ≥grade 2
• Known history of human immunodeficiency virus (HIV), or active hepatitis C Virus, or active hepatitis B Virus infection, or any uncontrolled active significant infection
• 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
• Have serious neurological or psychiatric history, can't normal study, including dementia, epilepsy, severe depression and mania
• Patients who were deemed by the investigator to be ineligible for enrollment

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Interventions

zanubrutinib; obinutuzumab; Prednisone; Cyclophosphamide; Vincristine; Doxorubicin

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Huilai Zhang, MD,PhD

CONTACT

0086-22-23359337; info@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 25, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 25, 2024

Record last verified: 2024-06