Current Clinical Trials

Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
  1. Constantin Dasanu, MD, PhD
    Constantin Dasanu, MD, PhD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started July 2023
  5. Constantin Dasanu, MD, PhD
  6. Accepting new patients

Description

Summary

This is a hybrid (retrospective and prospective), multicenter, non-interventional registry study. The primary objective of the study is to further describe the clinical profile of zanubrutinib in Treatment-naïve (TN) patients with MYD88 L265P mutation (MYD88L265P) Waldenström macroglobulinemia (WM), TN and Relapsed/Refractory (R/R) patients with non-L265P MYD88 mutation(s) and MYD88WT WM, and TN and R/R WM patients from racial and ethnic minority groups regardless of MYD88 status. Data collected from this registry study (newly registered patients and existing registries or databases) will be used to characterize the clinical benefit and safety of zanubrutinib for the treatment of patients in these populations.

Official Title

A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia (BGB-3111-402)

Keywords

Waldenstrom Macroglobulinemia

Eligibility

for people 18 Years and up
Inclusion Criteria: Clinical and definitive histologic diagnosis of WM Measurable disease, as defined by a serum immunoglobulin M (IgM) level > 0.5 g/dL at the time of zanubrutinib initiation Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM Bone marrow specimens with central MYD88 test results of: Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic pa... more
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Inclusion Criteria: Clinical and definitive histologic diagnosis of WM Measurable disease, as defined by a serum immunoglobulin M (IgM) level > 0.5 g/dL at the time of zanubrutinib initiation Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM Bone marrow specimens with central MYD88 test results of: Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic participant group when the required numbers of participants in the group are met Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT Exclusion Criteria: Evidence of disease transformation before the first dose of zanubrutinib Evidence of other non-Hodgkin Lymphoma (NHL) subtypes Prior or concurrent active malignancy ≤ 2 years before the first dose of zanubrutinib, except for malignancies that, in the investigator's opinion, will not obscure the interpretation of safety or efficacy results Concurrent participation in another therapeutic clinical study while receiving zanubrutinib, although the participant may be eligible depending on the status of the interventional study after discussion with the Medical Monitor or designee on an individual basis

Lead Scientists at Eisenhower Health

Constantin Dasanu, MD, PhD
Board Certified Medical Oncologist and Hematologist, Constantin Dasanu, MD, PhD, is dedicated to providing personalized cancer care for his patients and their families. He received his M.D. degree summa cum laude from the Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, and his Ph.D. in Immunology from the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. He completed his residency in Internal Medicine at the Albert Einstein College of Medicin... more
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Board Certified Medical Oncologist and Hematologist, Constantin Dasanu, MD, PhD, is dedicated to providing personalized cancer care for his patients and their families. He received his M.D. degree summa cum laude from the Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, and his Ph.D. in Immunology from the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. He completed his residency in Internal Medicine at the Albert Einstein College of Medicine in New York and his fellowship in Hematology/Oncology at New York Medical College. Dr. Dasanu also completed his training in Hematology & Transfusion Medicine in his home country Romania. 

“My immunology background offers me a unique clinical perspective as contemporary cancer therapies include a multitude of targeted agents, monoclonal antibodies, various biologics and vaccines,” states Dr. Dasanu. He treats patients with a variety of solid cancers, malignant melanoma and blood conditions. He serves as Director of Hematologic Malignancies at Eisenhower Lucy Curci Cancer Center (ELCCC). 

Dr. Dasanu is a Clinical Professor of Medicine at the University of California in San Diego, a major collaborative affiliate of ELCCC. He is the Director of Research at ELCCC and a principal investigator for a number of clinical trials. He presents his research findings at national and international conferences. He is the recipient of several teaching awards including the prestigious Thomas R. Preston MD Excellence in Teaching Award at the University of Connecticut in 2011. 

A prolific medical writer, Dr. Dasanu published more than 200 scientific and scholarly articles in prominent specialty journals including Journal of Clinical Oncology, New England Journal of Medicine, Journal of Thoracic Oncology and British Journal of Haematology among others. He is the editor of oncology sections at the Expert Opinion on Pharmacotherapy, Expert Opinion on Biological Therapy, and Current Medical Research and Opinion. He is a peer reviewer for Blood Journal and Leukemia Research. 

Armed with the knowledge of science, Dr. Dasanu feels that he can make a real difference in the lives of his patients. “The field is constantly changing and, therefore, I keep learning and constantly applying the most up-to-date, state-of-the-art treatments which ultimately benefit my patients,” states Dr. Dasanu. “My role is one of providing my patients with a medical plan that offers hope, but not false hope. Treating patients as unique individuals, with respect and compassion, and treating them as I would want to be treated are my ultimate goals in patient care.”

Clinical Study Details

  1. Accepting new patients
  2. study started July 2023
  3. Observational
  4. February 20, 2024