Neoplasms

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All Conditions

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Symptoms and General Pathology

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

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Disease Attributes

Acute Lymphoblastic Leukemia

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Acute Graft Versus Host Disease

patients diagnosed with acute lymphoblastic leukemia

patients diagnosed with chronic lymphocytic leukemia

patients diagnosed with non-Hodgkin lymphoma

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

clonoSEQ Assay

Heidi Simmons, PhD

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.

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.

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

The clonoSEQ® Watch Registry

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

Data will be collected to determine how the clonoSEQ Assay is used as part of routine disease response assessments in lymphoid malignancy patients

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The clonoSEQ® Watch Registry	NCT04545333	Acute Lymphobla... Chronic Lymphoc... Multiple Myelom... Non-hodgkin Lym...	clonoSEQ Assay	18 Years -	Adaptive Biotechnologies
The clonoSEQ® Watch Registry	NCT04545333	Acute Lymphobla... Chronic Lymphoc... Multiple Myelom... Non-hodgkin Lym...	clonoSEQ Assay	18 Years -	Adaptive Biotechnologies

Spots Global Cancer Trial Database for watch registry