Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Adaptive Biotechnologies
- Enrollment
- 465
- Locations
- 14
- Primary Endpoint
- Distribution of timepoints at which MRD is monitored using the clonoSEQ Assay in lymphoid malignancy patients in real world settings
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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):
- •ALL (B and T-cell subtypes)
- •B-cell NHL (all sub types)
- •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
Outcomes
Primary Outcomes
Distribution of timepoints at which MRD is monitored using the clonoSEQ Assay in lymphoid malignancy patients in real world settings
Time Frame: up to 3 yrs
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
Secondary Outcomes
- Numbers of lymphoid malignancy patients with de-intensifications to their drug regimens based upon clonoSEQ MRD results(up to 3 yrs)
- Numbers of lymphoid malignancy patients with intensifications to their drug regimens based upon clonoSEQ MRD results(up to 3 yrs)