A Single-arm, Single-center, Open-label Phase II Study of Zanubrutinib Combined With R-CHOP/R-DHAP in Newly Diagnosed Mantle CellLymphoma Patients

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanxi Province Cancer Hospital

About this trial

Evaluation the efficacy and safety of Zanubrutinib + R-CHOP/R-DHAP for the treatment mantle cell lymphoma.

Eligibility criteria

Qualifiers

Histologically confirmed diagnosis of MCL according to WHO classification;

Previously untreated MCL.

Age ≥ 18 and ≤ 70 years old.

ECOG, 0~2.

Disqualifiers

Known CNS involvement of MCL, Leukemic non-lymphonodular mantle cell lymphoma was excluded.

Major surgery within 4 weeks of screening

Concomitant or previous malignancies within the last 2 years other than basal cell skin cancer or in situ uterine cervix cancer

Clinically significant cardiovascular disease such as uncontrolled arrhythmias and hypertension , 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 LVEF below 50%(AHA,2016)

Trial design

Treatments tested in this trial

  • Zanubrutinib and RCHOP/RDHAP

Treatment groups

23 Participants
are divided into 1 treatment group