The clonoSEQ® Watch Registry

Adaptive Biotechnologies

Status: Terminated

Conditions: Multiple Myeloma; Acute Lymphoblastic Leukemia, Adult B-Cell; Non-hodgkin Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Diagnostic Test: clonoSEQ Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT04545333

ADAP-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 465 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

465 participants in 4 patient groups

ALL

Description:

patients diagnosed with acute lymphoblastic leukemia

Treatment:

Diagnostic Test: clonoSEQ Assay

CLL

Description:

patients diagnosed with chronic lymphocytic leukemia

Treatment:

Diagnostic Test: clonoSEQ Assay

MM

Description:

patients diagnosed with multiple myeloma

Treatment:

Diagnostic Test: clonoSEQ Assay

NHL

Description:

patients diagnosed with non-Hodgkin lymphoma

Treatment:

Diagnostic Test: clonoSEQ Assay