The clonoSEQ® Watch Registry

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04545333
• Other study ID #: ADAP-008
• Status: Active, not recruiting
• Start date: October 13, 2020
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Adaptive Biotechnologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 528
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• clonoSEQ Assay
minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells

Locations

Country	Name	City	State
United States	Hematology Oncology Clinic	Baton Rouge	Louisiana
United States	American Oncology Partners of Maryland	Bethesda	Maryland
United States	Novant Health	Charlotte	North Carolina
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Bon Secours St Francis	Greenville	South Carolina
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health & Science University, Knight Cancer Institute	Portland	Oregon
United States	Washington University	Saint Louis	Missouri
United States	Swedish Cancer Institute	Seattle	Washington
United States	University of Washington, Seattle Cancer Care Alliance	Seattle	Washington
United States	Edward H. Kaplan MD & Associates	Skokie	Illinois
United States	Stanford Hospital	Stanford	California
United States	Northwest Medical Specialties	Tacoma	Washington
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Adaptive Biotechnologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Average numbers of clonoSEQ Assay orders placed for enrolled lymphoid malignancy patients in routine clinical practice relative to other response assessments	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
Other	Differences in outcomes between clonoSEQ Assay MRD-negative and MRD-positive lymphoid malignancy patients	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
Primary	Distribution of timepoints at which MRD is monitored using the clonoSEQ Assay in lymphoid malignancy patients in real world settings	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	Numbers of lymphoid malignancy patients with intensifications to their drug regimens based upon clonoSEQ MRD results	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
Secondary	Numbers of lymphoid malignancy patients with de-intensifications to their drug regimens based upon clonoSEQ MRD results	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