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

June 19, 2024 updated by: Tianjin Medical University Cancer Institute and Hospital

A Study of the Zanubrutinib With G-CHOP Regimens in the Frontline Treatment of Intermediate-high Risk Follicular Lymphoma

: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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Huilai Zhang, MD,PhD
  • Phone Number: 0086-22-23359337
  • Email: info@tjmuch.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm

Induction: Zanubrutinib and G-CHOP 4-6cycles

Maintenance: Zanubrutinib and Obinutuzumab 1 year
Drug: Zanubrutinib
Zanubrutinib, 160mg PO BID.on days 1-28 Induction treatment: 4-6cycles ; Maintenance: 1 year;
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;
Drug: Prednisone
Prednisone (P), 100 mg, PO, D2-6；for 4-6 cycles for CHOP treatment , 1 cycle = 28 days
Drug: Cyclophosphamide
Cyclophosphamide (C), 750 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days
Drug: Vincristine
Vincristine (O), 1.4 mg/m2 (maximum 2 mg), IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days
Drug: Doxorubicin
Doxorubicin (H), 50 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment ，1 cycle = 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CR (complete response) rate after induction (4 or 6 Cycles) by investigator (INV)
Time Frame: From enrollment to the end of treatment at cycle 4 or 6 (each cycle is 28 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response rate after induction by investigator (INV)
Time Frame: From enrollment to the end of end of treatment at cycle 4 or 6 (each cycle is 28 days)
ORR is defined as the proportion of patients achieving complete response (CR) or partial response (PR), as determined by INV according to 2014 Lugano criteria
From enrollment to the end of end of treatment at cycle 4 or 6 (each cycle is 28 days)
Overall survival (OS)
Time Frame: From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years
Overall survival (OS) is defined as the duration from the date of initiation of the first cycle of treatment to the date of death because of any cause
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)
Time Frame: From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years
-PFS defined as time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by INV
From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TN-FL001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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