The clonoSEQ® Watch Registry

Trial ID or NCT#

NCT04545333

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Patients must be able to provide written informed consent2. A decision has been made by the treating provider to use the clonoSEQ Assay as part of routine clinical care3. Age ≥ 18 years;4. Documented hematologic malignancy (any of the below):
  2. 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:
  1. Patients must not meet any of the following criteria in order to be enrolled into the study:
    1. 1. Concurrent enrollment in a clinical trial where treatment decisions and patterns are dictated per protocol2. A decision has been made by the treating provider to not use the clonoSEQ Assay as part of routine clinical care

Investigator(s)

Lori Muffly
Lori Muffly
Hematologist, Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist-Oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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Contact

Janet McDowell