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NCT04624958Active, not recruitingPhase 2

Zanubrutinib and Rituximab Followed by R-DHAOx Then Maintenance with Zanubrutinib for Newly-Diagnosed MCL

Zanubrutinib and Rituximab Followed by R-DHAOx (Rituximab, Dexamethasone, Cytarabine and Oxaliplatin) Regimen Then Maintenance with Zanubrutinib for Newly-Diagnosed Mantle Cell Lymphoma (MCL): a Single Arm, Open Label, Multi-center Phase II Study

Source: ClinicalTrials.gov · Last updated 18 Oct 2024

Brief summary (registry, in English)

This phase 2 trial studies the efficacy and safety of zanubrutinib plus rituximab followed by R-DHAOx (rituximab, dexamethasone, cytarabine and oxaliplatin) regimen then maintenance with zanubrutinib for newly-diagnosed Mantle Cell Lymphoma (MCL).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
42 (actual)
First submitted
6 Nov 2020
Start date
1 Dec 2020
Primary completion date
Dec 2024
Lead sponsor
Sun Yat-sen University
NCT number
NCT04624958

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 42
  • From 1 Dec 2020 to the primary completion date, Dec 2024
  • 3 sites in 1 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

  • Patients require treatment with strong CYP3A inhibitors;
  • Diagnosed with or receiving treatment for malignancy other than lymphoma;

Other illness

  • Patients with Hemophagocytic syndrome;
  • Patients with active bleeding, bleeding tendency or require anticoagulation treatment;
  • Uncontrolled active infection, with the exception of tumor-related B symptom fever;
  • History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome are known;
  • Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA (no more than 1000 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 1000 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group;

Other

  • Involvement of central nervous system (CNS)
  • Pregnant or breastfeeding women;
  • Other researchers consider it unsuitable for patients to participate in this study.

Who the study is looking for

  • Histologically confirmed CD20 positive mantle cell lymphoma;
  • Patients with MCL-related symptomatic and need immediate therapy; Include any of the following: (1) Blastoid variant (2) Pleomorphic variant (3) Ki-67 ≥30% (4) Bulky mass \> 7 cm or ≥2 tumors, each ≥5 cm in diameter (5) Mutations in TP53, c-MYC or NOTCH genes (6) Size of spleen ≥20 cm (7) Lymphoma B symptoms (8) Mantle Cell International Prognostic Score (MIPI) \> 3 (9) Lymphoma threatening organ function (10) Elevated lactate dehydrogenase (11) Peripheral blood white blood cell \> 50×10\^9/L (12) Pancytopenia due to bone marrow involvement (13) Pain due to lymphoma;
  • Patients received no prior anti-lymphoma treatment;
  • At least one evaluable lesion according to 2014 Lugano criteria;
  • Ann Arbor stage II-IV;
  • Eastern Cooperative Oncology Group (ECOG) of 0-2;
  • Life expectancy \> 3 months;
  • Able to participate in all required study procedures;
  • Proper functioning of the major organs: 1) The absolute value of neutrophils (\>1.5×10\^9/L); 2) platelet count (\> 75×10\^9/L); 3) Hemoglobin (\> 80 g/L); 4) Serum creatinine \<1.5 times Upper Limit Normal (ULN) ; 5) Serum total bilirubin \< 1.5 times ULN; 6) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \< 2.5 times ULN; 7) Coagulation function: International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) \< 1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are within the expected range at screening time);

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Guangdong Pharmaceutical University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Guangdong General Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

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