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The clonoSEQ® Watch Registry

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ClinicalTrials.gov Identifier: NCT04545333
Recruitment Status : Recruiting
First Posted : September 11, 2020
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Adaptive Biotechnologies

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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia, Adult B-Cell Chronic Lymphocytic Leukemia Multiple Myeloma Non-hodgkin Lymphoma Diagnostic Test: clonoSEQ Assay

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.

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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 : April 2022
Estimated Study Completion Date : April 2024


Group/Cohort Intervention/treatment
ALL
patients diagnosed with acute lymphoblastic leukemia
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. 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

  2. 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
Remaining samples will be stored for potential use in future assay development research.


Information from the National Library of Medicine

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.


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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
Study Population
Adult patients with a diagnosis of ALL, MM, CLL, or NHL whose SOC response assessments will include monitoring of MRD status by clonoSEQ Assay
Criteria

Inclusion Criteria:

  1. Patients must be able to provide written informed consent
  2. A decision has been made by the treating provider to use the clonoSEQ Assay as part of routine clinical care
  3. Age ≥ 18 years;
  4. Documented hematologic malignancy (any of the below):

    1. MM
    2. ALL (B and T-cell subtypes)
    3. B-cell NHL (all sub types)
    4. CLL
    5. 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:

  1. Concurrent enrollment in a clinical trial where treatment decisions and patterns are dictated per protocol
  2. A decision has been made by the treating provider to not use the clonoSEQ Assay as part of routine clinical care

Information from the National Library of Medicine

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


Contacts
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Contact: Heidi Simmons, PhD 206-279-2591 hsimmons@adaptivebiotech.com
Contact: Mark Schliekelman, PhD 206-279-2508 mschliekelman@adaptivebiotech.com

Locations
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United States, California
Stanford Hospital Recruiting
Stanford, California, United States, 94305
Contact: Janet McDowell         
Principal Investigator: Lori Muffly, MD         
United States, Colorado
University of Colorado - Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Derek Schatz         
Principal Investigator: Tomer Mark, MD         
United States, District of Columbia
Georgetown University Not yet recruiting
Washington, District of Columbia, United States, 20007
Contact: Catherine Lai         
Principal Investigator: Catherine Lai         
United States, Florida
Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Eileen Georgi         
Principal Investigator: Georges Azzi         
United States, Illinois
Edward H. Kaplan MD & Associates Recruiting
Skokie, Illinois, United States, 60076
Contact: Marlon Kleinman         
Principal Investigator: Marlon Kleinman         
United States, Louisiana
Hematology Oncology Clinic Not yet recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Michael Castine         
Principal Investigator: Michael Castine         
United States, Maryland
American Oncology Partners of Maryland Recruiting
Bethesda, Maryland, United States, 20817
Contact: Bruce Cheson         
Principal Investigator: Bruce Cheson         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Mark Fiala         
Principal Investigator: Ravi Vij, MD         
United States, North Carolina
Novant Health Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Alan Skarbnik         
Principal Investigator: Alan Skarbnik         
United States, Oregon
Oregon Health & Science University, Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Tara Lundberg Williams         
Principal Investigator: Jessica Leonard, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kristy Walsh         
Principal Investigator: Jakub Svoboda, MD         
United States, South Carolina
Bon Secours St Francis Recruiting
Greenville, South Carolina, United States, 29607
Contact: Amy Adams         
Principal Investigator: Howland Crosswell, MD         
United States, Washington
University of Washington, Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98102
Contact: Peter Wilcox         
Principal Investigator: Andrew Cowan, MD         
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Krish Patel         
Principal Investigator: Krish Patel         
Northwest Medical Specialists Recruiting
Tacoma, Washington, United States, 98405
Contact: Emily Kerry         
Principal Investigator: Swathi Namburi, MD         
Northwest Medical Specialties Recruiting
Tacoma, Washington, United States, 98405
Contact: Swathi Namburi         
Principal Investigator: Swathi Namburi         
Sponsors and Collaborators
Adaptive Biotechnologies
Investigators
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Study Chair: John Pagel, MD, PhD Swedish Cancer Institute
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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: September 23, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Adaptive Biotechnologies:
Minimal residual disease
measurable residual disease
MRD
clonoSEQ
ALL
CLL
MM
NHL
Watch Registry
Additional relevant MeSH terms:
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Leukemia
Multiple Myeloma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Leukemia, Lymphoid
Leukemia, B-Cell