Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy

Completed

• Conditions: Acute Myelogenous Leukemia; Myeloproliferative Neoplasm; Myelodysplastic Syndromes; Multiple Myeloma; Lymphoma; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia

• Registration Number: NCT04014764
• Lead Sponsor: Notable Labs

Brief Summary

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.

Detailed Description

This is a prospective, multicenter, observational study with collection of de-identified biospecimens with matched clinical data from up to 1000 participants from clinical networks in the United States and Canada. Clinical information, demographics, and medical data relevant to cancer status are collected from all participants and their medical record at baseline (at study entry and time of baseline biospecimen collection), and subsequent visits per patient consent, for up to 1 year.

The primary assessment is the establishment of a tumor registry with annotated clinical outcomes. Exploratory assessments include correlation of ex vivo functional testing results with clinical outcomes, as well as identification of potential biomarkers that correlate responses with genotype and/or phenotype.

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-10
• Study Start: 2019-12-15
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical response to treatment	3 years	Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank

Secondary Outcome Measures

Name	Time	Method
Type of clinical treatment responses	3 years	Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses.
Types of somatic tumor mutations	3 years	Determine genotype and/or phenotype relationships between ex vivo and clinical responses with somatic tumor mutations.

Trial Locations

Locations (20)

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

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