A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Zanubrutinib
DrugPatients 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).
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-year progression-free survival (PFS)
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
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 yearsSecondary outcomes
1
2-year event-free survival (EFS)
the period from the date of patients sign informed consent to the observed event for any reason
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 years2
overall survival
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
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 years3
Hematology and non hematology toxicity
number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame
Through study completion, up to 2 years.4
Quality of life questionnaire
evaluate patients' quality of life by questionnaire.
Time frame
Up to 2 yearsOther outcomes
1
Exploratory biomarkers
Biomarkers for predictive factors of efficacy at baseline or during the treatment
Time frame
Throughout the treatment period, up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov