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
Qualifiers
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
Treatments tested in this trial
- Zanubrutinib
Treatment groups
52 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov