- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04545333
The clonoSEQ® Watch Registry
Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Heidi Simmons, PhD
- Phone Number: 206-279-2591
- Email: hsimmons@adaptivebiotech.com
Study Contact Backup
- Name: Mark Schliekelman, PhD
- Phone Number: 206-279-2508
- Email: mschliekelman@adaptivebiotech.com
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford Hospital
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University
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Florida
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Fort Lauderdale, Florida, United States, 33308
- Holy Cross Hospital
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Illinois
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Skokie, Illinois, United States, 60076
- Edward H. Kaplan MD & Associates
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Hematology Oncology Clinic
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Maryland
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Bethesda, Maryland, United States, 20817
- American Oncology Partners of Maryland
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Missouri
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Saint Louis, Missouri, United States, 63130
- Washington University
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Novant Health
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University, Knight Cancer Institute
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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South Carolina
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Greenville, South Carolina, United States, 29607
- Bon Secours St Francis
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Washington
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Seattle, Washington, United States, 98104
- Swedish Cancer Institute
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Seattle, Washington, United States, 98102
- University of Washington, Seattle Cancer Care Alliance
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Tacoma, Washington, United States, 98405
- Northwest Medical Specialties
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ALL
patients diagnosed with acute lymphoblastic leukemia
|
minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells
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CLL
patients diagnosed with chronic lymphocytic leukemia
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minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells
|
MM
patients diagnosed with multiple myeloma
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minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells
|
NHL
patients diagnosed with non-Hodgkin lymphoma
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minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells
|
What is the study measuring?
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
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
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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
Time Frame: up to 3 yrs
|
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
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up to 3 yrs
|
Numbers of lymphoid malignancy patients with de-intensifications to their drug regimens based upon clonoSEQ MRD results
Time Frame: up to 3 yrs
|
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
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up to 3 yrs
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average numbers of clonoSEQ Assay orders placed for enrolled lymphoid malignancy patients in routine clinical practice relative to other response assessments
Time Frame: up to 3 yrs
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Data will be collected to determine how the clonoSEQ Assay is used as part of routine disease response assessments in lymphoid malignancy patients
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up to 3 yrs
|
Differences in outcomes between clonoSEQ Assay MRD-negative and MRD-positive lymphoid malignancy patients
Time Frame: up to 3 yrs
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Data will be collected to assess the following, as applicable, depending upon distribution of patients that enroll in this study:
|
up to 3 yrs
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Heidi Simmons, PhD, Adaptive Biotechnologies
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Leukemia, Lymphoid
- Leukemia, B-Cell
- Chronic Disease
- Multiple Myeloma
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphocytic, Chronic, B-Cell
Other Study ID Numbers
- ADAP-008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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