Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy ((ANSWer))

Notable Labs

Status: Completed

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

Treatments: Other: This is a non-interventional study

Study type: Observational

Funder types: Industry

Identifiers

NCT04014764

N-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

119 participants in 1 patient group

Single group

Description:

Documented hematologic malignancy in need of starting an active anti-cancer therapy. This is a non-interventional study.

Treatment:

Other: This is a non-interventional study