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The clonoSEQ® Watch Registry
Trial Status: administratively complete
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.
Inclusion Criteria
Inclusion Criteria:
1. Patients must be able to provide written informed consent
2. A decision has been made by the treating provider to use the clonoSEQ Assay as part
of routine clinical care
3. Age ≥ 18 years;
4. Documented hematologic malignancy (any of the below):
1. MM
2. ALL (B and T-cell subtypes)
3. B-cell NHL (all sub types)
4. CLL
5. 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:
1. Concurrent enrollment in a clinical trial where treatment decisions and patterns are
dictated per protocol
2. A decision has been made by the treating provider to not use the clonoSEQ Assay as
part of routine clinical care
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04545333.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
District of Columbia
Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available
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
