Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy

Completed

Conditions studied: Acute Myelogenous Leukemia, Multiple Myeloma, Myelodysplastic Syndromes, Lymphoma, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myeloproliferative Neoplasm

In brief

This is a prospective, multicenter observational study to collect clinically annotated biospecimens in order to assess the correlation between ex vivo data generated by the Notable assay platform and clinical outcome.

Key facts

Study ID

NCT04014764

Run by

Notable Labs

People needed

119

Starts

2019-12-15

Expected to finish

2022-03-31

Last updated by the study team

2022-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent;
• Age ≥ 18 years, male or female, of any race;
• Documented hematologic malignancy (any of the below) in need of starting an active anti-cancer therapy:
• Acute myelogenous leukemia (AML)
• Multiple myeloma (MM)
• Myelodysplastic syndrome (MDS)
• Lymphoma
• Acute lymphocytic leukemia (ALL)
• Chronic lymphocytic leukemia (CLL)
• Chronic myelogenous leukemia (CML)
• Neoplasm (MPN)
• Other (upon review and approval by medical monitor)
• Note: *Supportive care agents including erythropoiesis-stimulating agents (ESAs) such as EPO, Procrit, Aranesp, etc; granulocyte colony stimulating factor (G-CSF); hydroxyurea (Hydrea); and luspatercept (Reblozyl) are not considered anti-cancer therapy for this study
• Intent to start anti-cancer therapy within 21 days of biospecimen collection
• ≥7 days from last anti-cancer therapy;
• Any number of prior therapies
• Subject cohort is currently open

You may not qualify if…

• Unwilling or unable to give consent
• Subject's disease is in remission
• Subject cohort is not open at time of consent
• Subject is restarting an ongoing treatment regimen after a dose interruption

Where it is running

• CBCC Global Research — Bakersfield, California, United States
• Pacific Central Coast Health Centers -- SLO Oncology and Hematology Health Center — San Luis Obispo, California, United States
• Colorado West Healthcare System, dba Grand Valley Oncology — Grand Junction, Colorado, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Mid Florida Hematology and Oncology Center — Orange City, Florida, United States
• Touro Infirmary — New Orleans, Louisiana, United States
• Northern Light Cancer Care Center — Brewer, Maine, United States
• New York Cancer and Blood Specialists — Port Jefferson Station, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• The Lindner Center for Research and Education at The Christ Hospital -- The Cancer Center — Cincinnati, Ohio, United States
• Utah Cancer Specialists — Salt Lake City, Utah, United States
• University Hospital of Alexandroupolis — Alexandroupoli, Greece
• National Kapodistrian University of Athens — Athens, Greece
• Attikon University Hospital — Athens, Greece
• National Kapodistrian Hospital/Laikon General Hospital — Athens, Greece
• University Hospital of Ioánnina — Ioannina, Greece
• University Hospital Patras — Pátrai, Greece
• Hospital General Universitario de Alicante — Alicante, Spain
• Hospital San Pedro de Alcántare — Cáceres, Spain
• Hospital Universitari I Politècnic La Fe — Valencia, Spain

Full record on ClinicalTrials.gov

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