The clonoSEQ® Watch Registry

Sponsor

Adaptive Biotechnologies (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04545333

Collaborator

(none)

528

Enrollment

Locations

41.6

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

528 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 13, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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

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
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

Other Outcome Measures

Average numbers of clonoSEQ Assay orders placed for enrolled lymphoid malignancy patients in routine clinical practice relative to other response assessments [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
Differences in outcomes between clonoSEQ Assay MRD-negative and MRD-positive lymphoid malignancy patients [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients must be able to provide written informed consent
A decision has been made by the treating provider to use the clonoSEQ Assay as part of routine clinical care
Age ≥ 18 years;
Documented hematologic malignancy (any of the below):
MM
ALL (B and T-cell subtypes)
B-cell NHL (all sub types)
CLL
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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Hospital	Stanford	California	United States	94305
2	University of Colorado - Anschutz Medical Campus	Aurora	Colorado	United States	80045
3	Georgetown University	Washington	District of Columbia	United States	20007
4	Holy Cross Hospital	Fort Lauderdale	Florida	United States	33308
5	Edward H. Kaplan MD & Associates	Skokie	Illinois	United States	60076
6	Hematology Oncology Clinic	Baton Rouge	Louisiana	United States	70809
7	American Oncology Partners of Maryland	Bethesda	Maryland	United States	20817
8	Washington University	Saint Louis	Missouri	United States	63130
9	Novant Health	Charlotte	North Carolina	United States	28204
10	Oregon Health & Science University, Knight Cancer Institute	Portland	Oregon	United States	97239
11	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
12	Bon Secours St Francis	Greenville	South Carolina	United States	29607
13	University of Washington, Seattle Cancer Care Alliance	Seattle	Washington	United States	98102
14	Swedish Cancer Institute	Seattle	Washington	United States	98104
15	Northwest Medical Specialists	Tacoma	Washington	United States	98405
16	Northwest Medical Specialties	Tacoma	Washington	United States	98405