This is a prospective, multicenter, observational study of adult patients with a diagnosis of acute lymphoblastic leukemia (ALL), multiple myeloma (MM), chronic lymphocytic leukemia (CLL), or non-Hodgkin lymphoma (NHL). This study will enroll up to 528 patients in up to 50 sites in the United States and collect data with regard to use of the clonoSEQ MRD assay in the management of lymphoid malignancies.
Data show that detection of MRD may be important to guide treatment decisions in ALL, MM, CLL, and NHL. However, there remains a lack of real-world evidence for making therapeutic decisions based upon MRD status. This study is designed to understand when in a patient's treatment continuum the assay is used and how clonoSEQ MRD data impact the treatment decisions made by investigators. All patients enrolled in the study will be followed for at least 2 yrs. Demographic data and disease status will be captured at study enrollment. Patients must be \>/= 18 yrs of age and able to sign informed consent. A given patient is eligible to enroll in the study if the treating physician has made the decision to use the clonoSEQ assay as part of that patient's routine cancer care. Reasons for placing a clonoSEQ order and subsequent decisions made as a result of MRD data will be tracked. Patient treatment will also be tracked over the course of the study in order to understand how clonoSEQ use is incorporated into current treatment regimens. Participating centers will include sites that actively use clonoSEQ to manage their patients with lymphoid malignancies.
Study Type
OBSERVATIONAL
Enrollment
465
minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells
Stanford Hospital
Stanford, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Distribution of timepoints at which MRD is monitored using the clonoSEQ Assay in lymphoid malignancy patients in real world settings
Data will be collected to determine at what points lymphoid malignancy patients are in their treatment continuums when the clonoSEQ Assay is used to monitor MRD levels
Time frame: up to 3 yrs
Numbers of lymphoid malignancy patients with intensifications to their drug regimens based upon clonoSEQ MRD results
Data will be collected with regard to changes to treatment/drug regimens in order to determine how clonoSEQ Assay MRD results inform and impact routine clinical practice
Time frame: up to 3 yrs
Numbers of lymphoid malignancy patients with de-intensifications to their drug regimens based upon clonoSEQ MRD results
Data will be collected with regard to changes to treatment/drug regimens in order to determine how clonoSEQ Assay MRD results inform and impact routine clinical practice
Time frame: up to 3 yrs
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Fort Lauderdale, Florida, United States
Edward H. Kaplan MD & Associates
Skokie, Illinois, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
American Oncology Partners of Maryland
Bethesda, Maryland, United States
Washington University
St Louis, Missouri, United States
Novant Health
Charlotte, North Carolina, United States
Oregon Health & Science University, Knight Cancer Institute
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
...and 4 more locations