The clonoSEQ® Watch Registry
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ClinicalTrials.gov Identifier: NCT04545333 |
Recruitment Status :
Active, not recruiting
First Posted : September 11, 2020
Last Update Posted : June 22, 2023
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Condition or disease | Intervention/treatment |
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Acute Lymphoblastic Leukemia, Adult B-Cell Chronic Lymphocytic Leukemia Multiple Myeloma Non-hodgkin Lymphoma | Diagnostic Test: clonoSEQ Assay |
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 : | Observational [Patient Registry] |
Estimated Enrollment : | 528 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 2 Years |
Official Title: | Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry |
Actual Study Start Date : | October 13, 2020 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |
Group/Cohort | Intervention/treatment |
---|---|
ALL
patients diagnosed with acute lymphoblastic leukemia
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Diagnostic Test: clonoSEQ Assay
minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells |
CLL
patients diagnosed with chronic lymphocytic leukemia
|
Diagnostic Test: clonoSEQ Assay
minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells |
MM
patients diagnosed with multiple myeloma
|
Diagnostic Test: clonoSEQ Assay
minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells |
NHL
patients diagnosed with non-Hodgkin lymphoma
|
Diagnostic Test: clonoSEQ Assay
minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells |
- 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
- 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
- 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
- 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 ]Data will be collected to determine how the clonoSEQ Assay is used as part of routine disease response assessments in lymphoid malignancy patients
- Differences in outcomes between clonoSEQ Assay MRD-negative and MRD-positive lymphoid malignancy patients [ Time Frame: up to 3 yrs ]
Data will be collected to assess the following, as applicable, depending upon distribution of patients that enroll in this study:
- Response to treatment, duration of response, time to next therapy, duration of maintenance therapy, and survival
- Numbers of patients who proceed to transplant in the ALL and MM cohorts
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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;
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545333
United States, California | |
Stanford Hospital | |
Stanford, California, United States, 94305 | |
United States, District of Columbia | |
Georgetown University | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Holy Cross Hospital | |
Fort Lauderdale, Florida, United States, 33308 | |
United States, Illinois | |
Edward H. Kaplan MD & Associates | |
Skokie, Illinois, United States, 60076 | |
United States, Louisiana | |
Hematology Oncology Clinic | |
Baton Rouge, Louisiana, United States, 70809 | |
United States, Maryland | |
American Oncology Partners of Maryland | |
Bethesda, Maryland, United States, 20817 | |
United States, Missouri | |
Washington University | |
Saint Louis, Missouri, United States, 63130 | |
United States, North Carolina | |
Novant Health | |
Charlotte, North Carolina, United States, 28204 | |
United States, Oregon | |
Oregon Health & Science University, Knight Cancer Institute | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, South Carolina | |
Bon Secours St Francis | |
Greenville, South Carolina, United States, 29607 | |
United States, Washington | |
University of Washington, Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98102 | |
Swedish Cancer Institute | |
Seattle, Washington, United States, 98104 | |
Northwest Medical Specialties | |
Tacoma, Washington, United States, 98405 |
Study Director: | Heidi Simmons, PhD | Adaptive Biotechnologies |
Responsible Party: | Adaptive Biotechnologies |
ClinicalTrials.gov Identifier: | NCT04545333 |
Other Study ID Numbers: |
ADAP-008 |
First Posted: | September 11, 2020 Key Record Dates |
Last Update Posted: | June 22, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Minimal residual disease measurable residual disease MRD clonoSEQ ALL |
CLL MM NHL Watch Registry |
Leukemia Multiple Myeloma Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Hematologic Diseases Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias |
Blood Protein Disorders Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Lymphatic Diseases Leukemia, Lymphoid Leukemia, B-Cell Chronic Disease Disease Attributes Pathologic Processes |