The clonoSEQ® Watch Registry

• ClinicalTrials.gov Identifier: NCT04545333
• Recruitment Status: Recruiting
• First Posted: September 11, 2020
• Last Update Posted: January 31, 2023
• Sponsor: Adaptive Biotechnologies
• Information provided by (Responsible Party): Adaptive Biotechnologies

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
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]
• Estimated Enrollment: 528 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Official Title: Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry
• Actual Study Start Date: October 13, 2020
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: April 2024

Groups and Cohorts

Group/Cohort	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 :

1. 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

Secondary Outcome Measures :

1. 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
2. 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

Other Outcome Measures:

1. 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
2. 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

Biospecimen Retention:   Samples With DNA

Remaining samples will be stored for potential use in future assay development research.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Criteria

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

Contacts and Locations

Contacts

Contact: Heidi Simmons, PhD; 206-279-2591; hsimmons@adaptivebiotech.com

Contact: Melissa Gonzales, PhD; mgonzales@adaptivebiotech.com

Locations

United States, California

Stanford Hospital; Recruiting

Stanford, California, United States, 94305

Contact: Janet McDowell

Principal Investigator: Lori Muffly, MD

United States, Colorado

University of Colorado - Anschutz Medical Campus; Recruiting

Aurora, Colorado, United States, 80045

Contact: Derek Schatz

Principal Investigator: Tomer Mark, MD

United States, District of Columbia

Georgetown University; Not yet recruiting

Washington, District of Columbia, United States, 20007

Contact: Catherine Lai

Principal Investigator: Catherine Lai

United States, Florida

Holy Cross Hospital; Recruiting

Fort Lauderdale, Florida, United States, 33308

Contact: Eileen Georgi

Principal Investigator: Georges Azzi

United States, Illinois

Edward H. Kaplan MD & Associates; Recruiting

Skokie, Illinois, United States, 60076

Contact: Marlon Kleinman

Principal Investigator: Marlon Kleinman

United States, Louisiana

Hematology Oncology Clinic; Not yet recruiting

Baton Rouge, Louisiana, United States, 70809

Contact: Michael Castine

Principal Investigator: Michael Castine

United States, Maryland

American Oncology Partners of Maryland; Recruiting

Bethesda, Maryland, United States, 20817

Contact: Bruce Cheson

Principal Investigator: Bruce Cheson

United States, Missouri

Washington University; Recruiting

Saint Louis, Missouri, United States, 63130

Contact: Mark Fiala

Principal Investigator: Ravi Vij, MD

United States, North Carolina

Novant Health; Recruiting

Charlotte, North Carolina, United States, 28204

Contact: Alan Skarbnik

Principal Investigator: Alan Skarbnik

United States, Oregon

Oregon Health & Science University, Knight Cancer Institute; Recruiting

Portland, Oregon, United States, 97239

Contact: Tara Lundberg Williams

Principal Investigator: Jessica Leonard, MD

United States, Pennsylvania

Hospital of the University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Kristy Walsh

Principal Investigator: Jakub Svoboda, MD

United States, South Carolina

Bon Secours St Francis; Recruiting

Greenville, South Carolina, United States, 29607

Contact: Amy Adams

Principal Investigator: Howland Crosswell, MD

United States, Washington

University of Washington, Seattle Cancer Care Alliance; Recruiting

Seattle, Washington, United States, 98102

Contact: Peter Wilcox

Principal Investigator: Andrew Cowan, MD

Swedish Cancer Institute; Recruiting

Seattle, Washington, United States, 98104

Contact: Krish Patel

Principal Investigator: Krish Patel

Northwest Medical Specialists; Recruiting

Tacoma, Washington, United States, 98405

Contact: Emily Kerry

Principal Investigator: Swathi Namburi, MD

Northwest Medical Specialties; Recruiting

Tacoma, Washington, United States, 98405

Contact: Swathi Namburi

Principal Investigator: Swathi Namburi

Sponsors and Collaborators

Adaptive Biotechnologies

Investigators

• Study Director: Heidi Simmons, PhD; Adaptive Biotechnologies

More Information

• Responsible Party: Adaptive Biotechnologies
• ClinicalTrials.gov Identifier: NCT04545333
• Other Study ID Numbers: ADAP-008
• First Posted: September 11, 2020
• Last Update Posted: January 31, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Keywords provided by Adaptive Biotechnologies:

Minimal residual disease; measurable residual disease; MRD; clonoSEQ; ALL; CLL; MM; NHL; Watch Registry

Additional relevant MeSH terms:

Leukemia; Multiple Myeloma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases; Leukemia, Lymphoid; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes