The clonoSEQ® Watch Registry

June 20, 2023 updated by: Adaptive Biotechnologies

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

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.

Study Overview

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

Observational

Enrollment (Estimated)

528

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • Stanford, California, United States, 94305
        • Stanford Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Edward H. Kaplan MD & Associates
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology Oncology Clinic
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • American Oncology Partners of Maryland
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Washington University
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University, Knight Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Bon Secours St Francis
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98102
        • University of Washington, Seattle Cancer Care Alliance
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
CLL
patients diagnosed with chronic lymphocytic leukemia
minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells
MM
patients diagnosed with multiple myeloma
minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells
NHL
patients diagnosed with non-Hodgkin lymphoma
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
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
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
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
Data will be collected to determine how the clonoSEQ Assay is used as part of routine disease response assessments in lymphoid malignancy patients
up to 3 yrs
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
up to 3 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Heidi Simmons, PhD, Adaptive Biotechnologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

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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