Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Observational Study to Collect and Assess Tissue Samples From Subjects With One of Three Neoplastic Conditions (ANSWer)

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

Intervention / Treatment
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* Other: This is a non-interventional study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single group<br>Documented hematologic malignancy in need of starting an active anti-cancer therapy. This is a non-interventional study. | Other: This is a non-interventional study<br>* N/A. This is a non-interventional study. Following consent, the subject will have biospecimen samples taken during routine standard of care procedures, and provided to Sponsor for analysis. Optional research blood draws may occur at treating physician's discretion to obtain additional tissue samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response to treatment | Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of clinical treatment responses | Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses. | 3 years | 
| Types of somatic tumor mutations | Determine genotype and/or phenotype relationships between ex vivo and clinical responses with somatic tumor mutations. | 3 years |