Clinical trial NCT04545333: The clonoSEQ® Watch Registry
Official title: Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Lymphoblastic Leukemia, Adult B-Cell
Chronic Lymphocytic Leukemia
Multiple Myeloma
Non-hodgkin Lymphoma
Keywords: Minimal residual disease
measurable residual disease
MRD
clonoSEQ
ALL
CLL
MM
NHL
Watch Registry
Lead sponsor: Adaptive Biotechnologies
Sponsor class: INDUSTRY
First posted: 2020-09-11
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: Distribution of timepoints at which MRD is monitored using the clonoSEQ Assay in lymphoid malignancy patients in real world settings
timeFrame: up to 3 yrs
Secondary outcomes:
measure: Numbers of lymphoid malignancy patients with intensifications to their drug regimens based upon clonoSEQ MRD results
timeFrame: up to 3 yrs
measure: Numbers of lymphoid malignancy patients with de-intensifications to their drug regimens based upon clonoSEQ MRD results
timeFrame: up to 3 yrs
Other outcomes:
measure: Average numbers of clonoSEQ Assay orders placed for enrolled lymphoid malignancy patients in routine clinical practice relative to other response assessments
timeFrame: up to 3 yrs
measure: Differences in outcomes between clonoSEQ Assay MRD-negative and MRD-positive lymphoid malignancy patients
timeFrame: up to 3 yrs
Locations:
city: Stanford
country: United States
facility: Stanford Hospital
state: California
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Skokie
country: United States
facility: Edward H. Kaplan MD & Associates
state: Illinois
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic
state: Louisiana
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland
state: Maryland
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Charlotte
country: United States
facility: Novant Health
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University, Knight Cancer Institute
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Greenville
country: United States
facility: Bon Secours St Francis
state: South Carolina
city: Seattle
country: United States
facility: University of Washington, Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
Study officials:
affiliation: Adaptive Biotechnologies
name: Heidi Simmons, PhD
role: STUDY_DIRECTOR
References: