An observational study in Acute Lymphoblastic Leukemia, Adult B-Cell, Chronic Lymphocytic Leukemia and Multiple Myeloma, sponsored by Adaptive Biotechnologies. Terminated at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by Adaptive Biotechnologies · Observational
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.
2,121 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 492 are open to participants now.
This study's enrollment of 465 is above the median of 120 across 313 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Adaptive Biotechnologies is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with a diagnosis of ALL, MM, CLL, or NHL whose SOC response assessments will include monitoring of MRD status by clonoSEQ Assay
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Documented hematologic malignancy (any of the below):
Exclusion Criteria:
Patients must not meet any of the following criteria in order to be enrolled into the study:
patients diagnosed with acute lymphoblastic leukemia
Diagnostic Test: clonoSEQ Assay
patients diagnosed with chronic lymphocytic leukemia
Diagnostic Test: clonoSEQ Assay
patients diagnosed with multiple myeloma
Diagnostic Test: clonoSEQ Assay
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
Distribution of timepoints at which MRD is monitored using the clonoSEQ Assay in lymphoid malignancy patients in real world settings
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
Time frame: up to 3 yrs
Numbers of lymphoid malignancy patients with intensifications to their drug regimens based upon clonoSEQ MRD results
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
Time frame: up to 3 yrs
Numbers of lymphoid malignancy patients with de-intensifications to their drug regimens based upon clonoSEQ MRD results
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
Time frame: up to 3 yrs
Average numbers of clonoSEQ Assay orders placed for enrolled lymphoid malignancy patients in routine clinical practice relative to other response assessments
Data will be collected to determine how the clonoSEQ Assay is used as part of routine disease response assessments in lymphoid malignancy patients
Time frame: up to 3 yrs
Differences in outcomes between clonoSEQ Assay MRD-negative and MRD-positive 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
Time frame: up to 3 yrs
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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