The clonoSEQ® Watch Registry

• ClinicalTrials.gov Identifier: NCT04545333
• Recruitment Status: Active, not recruiting
• First Posted: September 11, 2020
• Last Update Posted: June 22, 2023
• Sponsor: Adaptive Biotechnologies
• Information provided by (Responsible Party): Adaptive Biotechnologies

Tracking Information

• First Submitted Date: August 31, 2020
• First Posted Date: September 11, 2020
• Last Update Posted Date: June 22, 2023
• Actual Study Start Date: October 13, 2020
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 3, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 3, 2020)

• 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
• 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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: September 3, 2020)

• 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
• 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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: The clonoSEQ® Watch Registry
• Official Title: Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry
• 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 Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years

Biospecimen

Retention:   Samples With DNA

Description:

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

• 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

Condition

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

Intervention

Diagnostic Test: clonoSEQ Assay

minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells

Study Groups/Cohorts

• ALL
  patients diagnosed with acute lymphoblastic leukemia
  Intervention: Diagnostic Test: clonoSEQ Assay
• CLL
  patients diagnosed with chronic lymphocytic leukemia
  Intervention: Diagnostic Test: clonoSEQ Assay
• MM
  patients diagnosed with multiple myeloma
  Intervention: Diagnostic Test: clonoSEQ Assay
• NHL
  patients diagnosed with non-Hodgkin lymphoma
  Intervention: Diagnostic Test: clonoSEQ Assay

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 3, 2020): 528
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04545333
• Other Study ID Numbers: ADAP-008
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Adaptive Biotechnologies
• Original Responsible Party: Same as current
• Current Study Sponsor: Adaptive Biotechnologies
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Heidi Simmons, PhD; Adaptive Biotechnologies

• PRS Account: Adaptive Biotechnologies
• Verification Date: June 2023