This is a Phase II, Open-label, Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma

NCT06427213 | Not Yet Recruiting Phase 2

• 1 other identifier: IIT-TN MCL
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Lymphoma, Mantle-Cell; Lymphoma, Non-Hodgkin

Keywords

Zanubrutinib

Outcome Measures

Primary Outcomes (1)

• Objective Response rate after induction

  Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.

  3 yeas

Secondary Outcomes (5)

• Complete remission rate after Interim treatment

  3 years

• MRD negativity rate after induction

  3 years

• Progression free survival (PFS)

  5 years

• Overall survival (OS)

  5 years

• Percentage of Participants With Adverse Events

  5 years

Study Arms (2)

Elder Patients（≥65）

EXPERIMENTAL

Induction: Zanubrutinib and Obinutuzumab 1year Maintenance: Zanubrutinib continued until progression

Drug: Zanubrutinib,Obinutuzumab

Young Patients with High risk （≥18，<65）

EXPERIMENTAL

Induction: Zanubrutinib and R-BAC 6 cycles Consolidation: ASCT（If eligible for transplantation），Otherwise, the patient was directly entered into maintenance treatment Maintenance: Zanubrutinib continued until progression

Drug: Zanubrutinib and R-BAC

Interventions

Zanubrutinib,Obinutuzumab DRUG

Zanubrutinib, 160mg PO BID. C1D17 continuously for 1 year or until progressive disease； Obinutuzumab ：Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks，up to 20 doses. 1 cycle = 28 days. Maintenance: Zanubrutinib, 160mg PO BID

Elder Patients（≥65）

Zanubrutinib and R-BAC DRUG

Induction: Zanubrutinib and R-BAC 6 cycles Consolidation: ASCT（If eligible for transplantation），Otherwise, the patient was directly entered into maintenance treatment Maintenance: Zanubrutinib continued until progression

Young Patients with High risk （≥18，<65）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)，previous untreatment for mantle-cell lymphoma (MCL)
• The elderly group ≥65 years old;The young group was ≥18 years old and \< 65 years old.
• ECOG Performance Status 0-3
• Life expectancy of at least 3 months
• At least one evaluable lesion according to 2014 Lugano criteria;
• 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%

You may not qualify if:

• The presence of other tumors could affect the study medication or interfere with the results;
• Patients require treatment with strong or moderate CYP3A inhibitors;
• Pregnant or lactating women;
• Known to be allergic to the test drug ingredients;
• Subjects of childbearing potential who are unwilling to use highly effective contraceptive methods;
• Live vaccination was administered within 28 days prior to treatment
• 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;
• Severe coagulopathy and serious impairment of heart, brain, lung, liver, kidney and other organs
• History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;
• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Lymphoma, Non-Hodgkin

Interventions

zanubrutinib; obinutuzumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

keshu Zhou

CONTACT

0371-65587306; drzhouks77@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 23, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2029
• Last Updated: May 23, 2024

Record last verified: 2024-01