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

• ClinicalTrials.gov Identifier: NCT04014764
• Recruitment Status: Recruiting
• First Posted: July 10, 2019
• Last Update Posted: February 13, 2020
• Sponsor: Notable Labs
• Information provided by (Responsible Party): Notable Labs

Study Description

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.

Condition or disease	Intervention/treatment
Acute Myelogenous Leukemia; Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Myeloproliferative Neoplasm	Other: This is a non-interventional study

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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 1000 participants
• Observational Model: Other
• Time Perspective: Prospective
• Target Follow-Up Duration: 1 Year
• Official Title: An Observational Study to Collect and Assess Tissue Samples From Subjects With One of Three Neoplastic Conditions (ANSWer)
• Actual Study Start Date: December 15, 2019
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: September 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
Single group; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Clinical response to treatment [ Time Frame: 3 years ]
   Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank

Secondary Outcome Measures :

1. Type of clinical treatment responses [ Time Frame: 3 years ]
   Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses.
2. Types of somatic tumor mutations [ Time Frame: 3 years ]
   Determine genotype and/or phenotype relationships between ex vivo and clinical responses with somatic tumor mutations.

Biospecimen Retention:   Samples With DNA

The study will require tissue samples taken from consented subjects to be assayed using Notable's ex vivo, high-throughput flow cytometry based platform. The result of this assay will be compared to the subject's documented diagnosis as well as clinical outcome, where applicable. Additional biomarker testing, such as sequencing to determine somatic mutations using targeted panels, may also be conducted.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Approximately 1000 Subjects with diagnosed with a hematological malignancy will be enrolled to provide at least 1000 biospecimen samples.

Criteria

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)
• ≥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

Contacts and Locations

Contacts

Contact: Donna M Stram; 9783400869; DONNA@CHIMERACLINICAL.COM

Contact: Susanna Wen

Locations

United States, California

CBCC Global Research; Recruiting

Bakersfield, California, United States, 93309

Contact: Rose Perez 661-862-7178

Principal Investigator: Pradip Rustagi, MD

Sub-Investigator: David Kanamori, MD

Sub-Investigator: Ravindranath Patel, MD

Sub-Investigator: Kristi Mendez, MD

Sub-Investigator: Susana Bell, MD

Sub-Investigator: Kathy Jo Robb, MD

Pacific Central Coast Health Centers -- SLO Oncology and Hematology Health Center; Not yet recruiting

San Luis Obispo, California, United States, 93401

Contact: Amy Hidalgo 805-543-5577 Amy.hidalgo@dignityhealth.org

Principal Investigator: Thomas Spillane, MD

Sub-Investigator: James Link, MD

Sub-Investigator: Gorgun Akpek, MD

Sub-Investigator: Diane DeVos-Schmidt, MD

United States, Colorado

Colorado West Healthcare System, dba Grand Valley Oncology; Recruiting

Grand Junction, Colorado, United States, 81505

Contact: Brandy Martin 970-644-3180 gvoclinicaltrials@gjhosp.org

Principal Investigator: Jonathan King, MD

Sub-Investigator: Joanne Virgilio, MD

Sub-Investigator: Sudy Jahangiri

Sub-Investigator: Kathryn Tarman

Sub-Investigator: Diane Melancon

Sub-Investigator: Andrea Liggett

Sub-Investigator: Kristina Goutsouliak

United States, Florida

Ocala Oncology Center; Recruiting

Ocala, Florida, United States, 34474

Contact: Sanjit Nirmalanandhan 352-547-1958 Sanjit.nirmalanandhan@usoncology.com

Principal Investigator: Anju Vasudevan, MD

Sub-Investigator: Rama Balaraman

Sub-Investigator: Ketan Doshi

Sub-Investigator: Lorelly Mobley

Sub-Investigator: Samuel Myrick

Sub-Investigator: Jennifer Sinquefield

Mid Florida Hematology and Oncology Center; Recruiting

Orange City, Florida, United States, 32763

Contact: Mahesh Nelakurthi 386-774-1223 mahesh@aorcorp.com

Principal Investigator: Santosh Nair, MD

Sub-Investigator: Bushra Ajaz, MD

Sub-Investigator: Renee Cabeza, MD

Sub-Investigator: Niraj Sharma, MD

Sub-Investigator: Banu Visvalingam, MD

Sub-Investigator: Sarah Roche, MD

United States, Ohio

The Lindner Center for Research and Education at The Christ Hospital -- The Cancer Center; Recruiting

Cincinnati, Ohio, United States, 45219

Contact: Lisa Woste, RN 513-585-0844 Lisa.woeste@thechristhospital.com

Principal Investigator: Gina Chung, MD

Sub-Investigator: Robert Cody, MD

Sub-Investigator: Bhandari Manish, MD

Sub-Investigator: Irfan Firdaus, MD

Sub-Investigator: Brian Mannion, MD

Sub-Investigator: Slobodan Stanisic, MD

Sub-Investigator: Jamie Waselenko, MD

Sub-Investigator: Weipang Zhang, MD

Sponsors and Collaborators

Notable Labs

Investigators

• Principal Investigator: Hiroomi Tada, MD, Ph.D.; Notable Labs

More Information

Additional Information:

Site Feasibility Questionnaire, public study information 

• Responsible Party: Notable Labs
• ClinicalTrials.gov Identifier: NCT04014764
• Other Study ID Numbers: N-01
• First Posted: July 10, 2019
• Last Update Posted: February 13, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Leukemia; Multiple Myeloma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Myeloproliferative Disorders; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Leukemia, Lymphoid; Lymphatic Diseases