Non Hodgkin Lymphoma Clinical Trial
The clonoSEQ® Watch Registry
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Patients must be able to provide written informed consent
A decision has been made by the treating provider to use the clonoSEQ Assay as part of routine clinical care
Age ≥ 18 years;
Documented hematologic malignancy (any of the below):
MM
ALL (B and T-cell subtypes)
B-cell NHL (all sub types)
CLL
Other lymphoid malignancies (upon review and approval by study chair)
Exclusion Criteria:
Patients must not meet any of the following criteria in order to be enrolled into the study:
Concurrent enrollment in a clinical trial where treatment decisions and patterns are dictated per protocol
A decision has been made by the treating provider to not use the clonoSEQ Assay as part of routine clinical care
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There are 14 Locations for this study
Stanford California, 94305, United States
Washington District of Columbia, 20007, United States
Fort Lauderdale Florida, 33308, United States
Skokie Illinois, 60076, United States
Baton Rouge Louisiana, 70809, United States
Bethesda Maryland, 20817, United States
Saint Louis Missouri, 63130, United States
Charlotte North Carolina, 28204, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19104, United States
Greenville South Carolina, 29607, United States
Seattle Washington, 98102, United States
Seattle Washington, 98104, United States
Tacoma Washington, 98405, United States
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