The clonoSEQ® Watch Registry

Terminated

• Conditions: Chronic Lymphocytic Leukemia; Non-hodgkin Lymphoma; Acute Lymphoblastic Leukemia, Adult B-Cell; Multiple Myeloma
• Interventions: Diagnostic Test: clonoSEQ Assay

• Registration Number: NCT04545333
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-11
• Study Start: 2020-10-13
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 465

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MM	clonoSEQ Assay	patients diagnosed with multiple myeloma
ALL	clonoSEQ Assay	patients diagnosed with acute lymphoblastic leukemia
CLL	clonoSEQ Assay	patients diagnosed with chronic lymphocytic leukemia
NHL	clonoSEQ Assay	patients diagnosed with non-Hodgkin lymphoma

Primary Outcome Measures

Name	Time	Method
Distribution of timepoints at which MRD is monitored using the clonoSEQ Assay in lymphoid malignancy patients in real world settings	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

Name	Time	Method
Numbers of lymphoid malignancy patients with de-intensifications to their drug regimens based upon clonoSEQ MRD results	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 intensifications to their drug regimens based upon clonoSEQ MRD results	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

Trial Locations

Locations (14)

University of Washington, Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

Oregon Health & Science University, Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States

Hematology Oncology Clinic; 🇺🇸 Baton Rouge, Louisiana, United States

American Oncology Partners of Maryland; 🇺🇸 Bethesda, Maryland, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Holy Cross Hospital; 🇺🇸 Fort Lauderdale, Florida, United States

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

Novant Health; 🇺🇸 Charlotte, North Carolina, United States

Stanford Hospital; 🇺🇸 Stanford, California, United States

Edward H. Kaplan MD & Associates; 🇺🇸 Skokie, Illinois, United States

Bon Secours St Francis; 🇺🇸 Greenville, South Carolina, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Northwest Medical Specialties; 🇺🇸 Tacoma, Washington, United States