NCT04545333

The clonoSEQ® Watch Registry

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 465 (actual)
• Sponsor: Adaptive Biotechnologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	clonoSEQ Assay	minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells

Timeline

• Start date: 2020-10-13
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2020-09-11
• Last updated: 2024-08-01

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study