The clonoSEQ® Watch Registry

NCT ID: NCT04545333

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

465 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-13

Study Completion Date

2023-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Lymphoblastic Leukemia, Adult B-Cell Chronic Lymphocytic Leukemia Multiple Myeloma Non-hodgkin Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ALL

patients diagnosed with acute lymphoblastic leukemia

clonoSEQ Assay

Intervention Type DIAGNOSTIC_TEST

minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells

CLL

patients diagnosed with chronic lymphocytic leukemia

clonoSEQ Assay

Intervention Type DIAGNOSTIC_TEST

minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells

MM

patients diagnosed with multiple myeloma

clonoSEQ Assay

Intervention Type DIAGNOSTIC_TEST

minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells

NHL

patients diagnosed with non-Hodgkin lymphoma

clonoSEQ Assay

Intervention Type DIAGNOSTIC_TEST

minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells

Interventions

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clonoSEQ Assay

minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adaptive Biotechnologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heidi Simmons, PhD

Role: STUDY_DIRECTOR

Adaptive Biotechnologies

Locations

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Stanford Hospital

Stanford, California, United States

Site Status

Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

Edward H. Kaplan MD & Associates

Skokie, Illinois, United States

Site Status

Hematology Oncology Clinic

Baton Rouge, Louisiana, United States

Site Status

American Oncology Partners of Maryland

Bethesda, Maryland, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Novant Health

Charlotte, North Carolina, United States

Site Status

Oregon Health & Science University, Knight Cancer Institute

Portland, Oregon, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Bon Secours St Francis

Greenville, South Carolina, United States

Site Status

University of Washington, Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Northwest Medical Specialties

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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ADAP-008

Identifier Type: -

Identifier Source: org_study_id

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