Study Stopped
Sufficient data collected.
The clonoSEQ® Watch Registry
Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry
1 other identifier
observational
465
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2020
CompletedFirst Posted
Study publicly available on registry
September 11, 2020
CompletedStudy Start
First participant enrolled
October 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedAugust 1, 2024
July 1, 2024
3 years
August 31, 2020
July 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Numbers of lymphoid malignancy patients with intensifications to their drug regimens based upon clonoSEQ MRD results
up to 3 yrs
Numbers of lymphoid malignancy patients with de-intensifications to their drug regimens based upon clonoSEQ MRD results
up to 3 yrs
Other Outcomes (2)
Average numbers of clonoSEQ Assay orders placed for enrolled lymphoid malignancy patients in routine clinical practice relative to other response assessments
up to 3 yrs
Differences in outcomes between clonoSEQ Assay MRD-negative and MRD-positive lymphoid malignancy patients
up to 3 yrs
Study Arms (4)
ALL
patients diagnosed with acute lymphoblastic leukemia
CLL
patients diagnosed with chronic lymphocytic leukemia
MM
patients diagnosed with multiple myeloma
NHL
patients diagnosed with non-Hodgkin lymphoma
Interventions
minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells
Eligibility Criteria
Adult patients with a diagnosis of ALL, MM, CLL, or NHL whose SOC response assessments will include monitoring of MRD status by clonoSEQ Assay
You may qualify if:
- 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)
- CLL
- Other lymphoid malignancies (upon review and approval by study chair)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Stanford Hospital
Stanford, California, 94305, United States
Georgetown University
Washington D.C., 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
St 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
Biospecimen
Remaining samples will be stored for potential use in future assay development research.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Heidi Simmons, PhD
Adaptive Biotechnologies
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2020
First Posted
September 11, 2020
Study Start
October 13, 2020
Primary Completion
October 1, 2023
Study Completion
October 1, 2023
Last Updated
August 1, 2024
Record last verified: 2024-07