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NCT06427213Not yet recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 23 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
41 (estimated)
First submitted
19 May 2024
Start date
20 May 2024
Primary completion date
30 Dec 2027
Lead sponsor
Henan Cancer Hospital
NCT number
NCT06427213

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 41
  • From 20 May 2024 to the primary completion date, 30 Dec 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The presence of other tumors could affect the study medication or interfere with the results;
  • Patients require treatment with strong or moderate CYP3A inhibitors;
  • Live vaccination was administered within 28 days prior to treatment

Other illness

  • Known to be allergic to the test drug ingredients;
  • 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.

Other

  • Pregnant or lactating women;
  • Subjects of childbearing potential who are unwilling to use highly effective contraceptive methods;

Who the study is looking for

  • 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%

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.