Clinical trial · Interventional
This is a Phase II, Open-label, Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma
A Study of the Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma
NCT06427213CI-TRIAL-00077406not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Mantle-Cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zanubrutinib and R-BAC | Drug | — | UNRESOLVED |
| Zanubrutinib,Obinutuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Elder Patients(≥65)
- description
- Induction: Zanubrutinib and Obinutuzumab 1year Maintenance: Zanubrutinib continued until progression
- interventionNames
- Drug: Zanubrutinib,Obinutuzumab
- type
- EXPERIMENTAL
- label
- Young Patients with High risk (≥18,<65)
- description
- 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
- interventionNames
- Drug: Zanubrutinib and R-BAC
Primary outcomes (1)
- measure
- Objective Response rate after induction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.