The clonoSEQ® Watch Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry

Conditions
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Acute Lymphoblastic Leukemia, Adult B-Cell, Chronic Lymphocytic Leukemia, Multiple Myeloma, Non-hodgkin Lymphoma

Intervention / Treatment
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* Diagnostic Test: clonoSEQ Assay


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALL<br>patients diagnosed with acute lymphoblastic leukemia | Diagnostic Test: clonoSEQ Assay<br>* minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells<br>|
| CLL<br>patients diagnosed with chronic lymphocytic leukemia | Diagnostic Test: clonoSEQ Assay<br>* minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells<br>|
| MM<br>patients diagnosed with multiple myeloma | Diagnostic Test: clonoSEQ Assay<br>* minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells<br>|
| NHL<br>patients diagnosed with non-Hodgkin lymphoma | Diagnostic Test: clonoSEQ Assay<br>* minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 3 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | up to 3 yrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clonoSEQ, ALL, CLL, MM, NHL, Watch Registry, Minimal residual disease, measurable residual disease, MRD