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.

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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.

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

528

Study ID:

NCT04545333

Recruitment Status:

Active, not recruiting

Sponsor:

Adaptive Biotechnologies

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There are 14 Locations for this study

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Stanford Hospital
Stanford California, 94305, United States
Georgetown University
Washington District of Columbia, 20007, United States
Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
Edward H. Kaplan MD & Associates
Skokie Illinois, 60076, United States
Hematology Oncology Clinic
Baton Rouge Louisiana, 70809, United States
American Oncology Partners of Maryland
Bethesda Maryland, 20817, United States
Washington University
Saint Louis Missouri, 63130, United States
Novant Health
Charlotte North Carolina, 28204, United States
Oregon Health & Science University, Knight Cancer Institute
Portland Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Bon Secours St Francis
Greenville South Carolina, 29607, United States
University of Washington, Seattle Cancer Care Alliance
Seattle Washington, 98102, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

528

Study ID:

NCT04545333

Recruitment Status:

Active, not recruiting

Sponsor:


Adaptive Biotechnologies

How clear is this clinincal trial information?

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