Clinical trial NCT06427213: This is a Phase II, Open-label, Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma
Official title: A Study of the Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Keywords: Zanubrutinib
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma.

Detailed description: This study is a prospective, multicenter, investigator-initiated clinical trial to evaluate the efficacy and safety of zanubrutinib-containing regimens in the treatment of newly diagnosed elderly or young patients with high risk MCL, aiming to find a more optimal treatment regimen for elderly or young patients with high risk MCL to improve the efficacy, survival time and quality of life of patients.

In elderly patients arm：patients start with the induction therapy of zanubrutinib combined with obinutuzumab for 1 year and then entered the maintenance therapy of zanubrutinib orally until intolerable toxicity or disease progression

In young patients with high risk arm：patiens \<65 years，and meet one or more of the following risk factors: TP53 mutation, blastoid/pleomorphic type, high sMIPI score. patients start with 6 cycles of induction therapy with zanubrutinib combined with R-BAC regimen, and the patients who achieve CR/PR and meet the transplantation criteria will receive ASCT consolidationand, then received maintenance therapy with zanubrutinib. otherwise, Patients who is ineligible for transplantation，will take zanubrutinib orally until intolerable toxicity or disease progression.

Eligibility criteria: Inclusion Criteria:

1. Voluntary participation in clinical study; Fully understand and understand the study and sign the informed consent form (ICF);Willingness to follow and ability to complete all study steps
2. Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)，previous untreatment for mantle-cell lymphoma (MCL)
3. The elderly group ≥65 years old;The young group was ≥18 years old and \< 65 years old.
4. ECOG Performance Status 0-3
5. Life expectancy of at least 3 months
6. At least one evaluable lesion according to 2014 Lugano criteria;
7. Proper functioning of the major organs, no major heart, lung, liver, kidney, or immunodeficiency (no blood transfusion, granulocyte colony-stimulating factor, or other medical support within 7 days before starting the study) :Hemoglobin (HB)≥60 g/L;Absolute neutrophil count(ANC)≥0.5×10\^9/L;Platelet count（PLT）≥50×10\^9/L;AST and ALT ≤ 2.5 x ULN；Total bilirubin ≤ 1.5 times the ULN;Ccr≥40ml/min（Cockcroft-Gault ）；Left Ventricular Ejection Fraction (LVEF) ≥ 50%

Exclusion Criteria:

1. The presence of other tumors could affect the study medication or interfere with the results;
2. Patients require treatment with strong or moderate CYP3A inhibitors;
3. Pregnant or lactating women;
4. Known to be allergic to the test drug ingredients;
5. Subjects of childbearing potential who are unwilling to use highly effective contraceptive methods;
6. Live vaccination was administered within 28 days prior to treatment
7. Known human immunodeficiency virus (HIV) infection or suggested active B or C infection The following serologic status of hepatitis C virus infection: 1) Hepatitis B virus (HBV) DNA positive. Positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B core antibody (HBcAb) seropositive if HBV DNA is undetectable and willing to accept Monthly surveillance for HBV reactivation was eligible. 2) Hepatitis C virus (HCV) antibody positive. For patients with HCV antibodies present, if undetectable HCV RNA, can be included;
8. Severe coagulopathy and serious impairment of heart, brain, lung, liver, kidney and other organs
9. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;
10. Any risk that is considered by the investigator to be likely to affect the safety of the subjects or to pose a risk to the study And vital diseases, medical conditions, or organ system insufficiency.

Primary outcomes:
measure: Objective Response rate after induction
timeFrame: 3 yeas
Secondary outcomes:
measure: Complete remission rate after Interim treatment
timeFrame: 3 years
measure: MRD negativity rate after induction
timeFrame: 3 years
measure: Progression free survival (PFS)
timeFrame: 5 years
measure: Overall survival (OS)
timeFrame: 5 years
measure: Percentage of Participants With Adverse Events
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References: