A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma

August 30, 2024 updated by: Yizhen Liu, Fudan University

Zanubrutinib for Maintenance Therapy in Patients With Mantle Cell Lymphoma Who Have Remission After First-line Immunochemotherapy- a Multicenter, Prospective, Phase II Study

This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of patients with mantle cell lymphoma who had remission after first-line immunochemotherapy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, patients diagnosed with mantle cell lymphoma who have achieved remission (CR or PR) by first-line immunochemotherapy, will be treated with Zanubrutinib monotherapy for 2 years (or until PD, intolerable toxicity, death, withdrawal, or study termination). This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of those patients, and explore the efficiency and safety.

Study Type

Interventional

Enrollment (Estimated)

52

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: Yizhen Liu, M.D., Ph.D.
  • Phone Number: 02164175590
  • Email: aliuyz@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Shanghai Cancer center
        • Contact:

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:

  • Age ≥ 18 years old;
  • Histologically confirmed mantle cell lymphoma (MCL);
  • Achieved complete response (CR) or partial response (PR) through first-line sufficient treatment (including immunochemotherapy with CD20 monoclonal antibody for at least 4 cycles). Frontline induction programs include but are not limited to: R-CHOP/R-DHAP, R-CHOP, BR, etc. Previous autologous hematopoietic stem cell transplantation is allowed;
  • ECOG 0-2;
  • Signed informed consent form;
  • Having sufficient organ function: a) Hematopoietic function: Neutrophils ≥ 1.0 × 109/L, PLT ≥ 50 × 109/L, Hb ≥ 80g/L; b) Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN), ALT and AST<3 x ULN, serum albumin ≥ 30 g/L; c) Renal function: serum Cr<1.5 × ULN, creatinine clearance rate ≥ 50mL/min (calculated according to the standard Cockcroft Gault formula, if renal dysfunction is caused by tumor compression, creatinine clearance rate ≥ 30mL/min); d) Left ventricular ejection fraction (LVEF) ≥ 50% detected by echocardiography; e) Coagulation function (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant therapy at the time of screening): International standardized ratio (INR) ≤ 1.5 x ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.

Exclusion Criteria:

  • Individuals who are allergic to human or mouse monoclonal antibodies and have been confirmed to be allergic to Zanubrutinib capsules and/or their excipients;
  • Recent major surgery (within 4 weeks prior to enrollment), excluding diagnostic surgery;
  • Uncontrollable concurrent diseases (cardiovascular and cerebrovascular diseases, blood coagulation disorders, severe infectious diseases) include but are not limited to: severe acute or chronic infections requiring systemic treatment, symptomatic congestive heart failure (New York Heart Association classification III-IV) or symptomatic or poorly controlled arrhythmias Uncontrolled arterial hypertension (systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg), unstable angina, active peptic ulcer, or hemorrhagic disease even after receiving standardized treatment;
  • Serious accompanying diseases that interfere with conventional treatment;
  • Has a history of active malignant tumors. Except for patients with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma in situ who have received possible curative treatment and have no disease recurrence within 3 years since the start of treatment;
  • Known to have active interstitial pneumonia;
  • Known cases of alcohol or drug abuse;
  • Active chronic hepatitis B infection (defined as HBV DNA positive): If hepatitis B virus (HBV) DNA cannot be detected during screening, patients with latent or previous hepatitis B infection (defined as positive hepatitis B surface antigen or hepatitis B core total antibody) can be included in this study. The above patients must voluntarily undergo regular HBV-DNA testing and receive appropriate antiviral treatment according to regulations. For patients with positive hepatitis C virus (HCV) antibody serological test, only when polymerase chain reaction (PCR) shows negative HCV-RNA can participate in this study.
  • Patients with active HIV and syphilis infections;
  • Pregnant or lactating women;
  • live vaccine administered within 4 weeks prior to administering the investigational drug, inactivated virus vaccines such as for seasonal influenza are allowed;
  • Continuous corticosteroid treatment currently being received, with a dose greater than 30mg/day of prednisone or equivalent medication for at least 10 days of continuous treatment;
  • Suffering from active autoimmune diseases that require systematic treatment within the past 2 years (Hormone replacement therapy is not considered as a systematic treatment, such as type I diabetes, hypothyroidism patients who only need thyroid hormone replacement therapy, patients with adrenocortical or pituitary dysfunction who only need physiological dose of glucocorticoid replacement therapy can be included in the group, and patients with autoimmune diseases who do not need systematic treatment in the past 2 years can be included in the group);
  • Patients with swallowing disorders who are unable to take medication orally for a long time;
  • Individuals with mental disorders who affect compliance and are unable to obtain informed consent;
  • The researcher determined that patients are not suitable to participate in this study.

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: Experimental group
maintenance of zanubrutinib monotherapy
Drug: Zanubrutinib
Patients diagnosed with mantle cell lymphoma who have achieved remission (CR or PR) by first-line immunochemotherapy, will be treated with Zanubrutinib monotherapy for 2 years (or until PD, intolerable toxicity, death, withdrawal, or study termination).
Other Names:
  • Maintenance therapy with Zanubrutinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year progression-free survival (PFS)
Time Frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
2-year event-free survival (EFS)
Time Frame: From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years
the period from the date of patients sign informed consent to the observed event for any reason
From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years
Hematology and non hematology toxicity
Time Frame: Through study completion, up to 2 years.
number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Through study completion, up to 2 years.
Quality of life questionnaire
Time Frame: Up to 2 years
evaluate patients' quality of life by questionnaire.
Up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory biomarkers
Time Frame: Throughout the treatment period, up to 2 years
Biomarkers for predictive factors of efficacy at baseline or during the treatment
Throughout the treatment period, up to 2 years

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Yizhen Liu, M.D., Ph.D., Fudan University

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 (Actual)

May 24, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iNHL-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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