iCare for Cancer Patients

The purpose of this study is to use genomic information from individual patients to create simulation avatars that will be used to predict novel drug combinations with therapeutic potential.

Study Overview

• Status: Terminated
• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes; Multiple Myeloma; Myelofibrosis; Acute Myelogenous Leukemia; Acute Lymphoid Leukemia; Leukemia, Acute Lymphoblastic
• Intervention / Treatment: Genetic: Molecular diagnostic testing

Detailed Description

As part of normal clinical care, subjects will undergo peripheral blood draws and biopsies for disease assessment of their cancer. In cases of hematological malignancies, bone marrow aspiration & biopsy are routinely performed.

As part of this project, the following will be done to the samples collected and with clinical outcomes data:

• donate peripheral blood specimens whenever blood is already being drawn for clinical purposes.
• donate bone marrow aspiration samples whenever a bone marrow aspiration procedure is already being done for clinical purposes.
• donate saliva whenever blood draw is already being done for clinical purposes.
• allow the investigators to perform gene mutation profiling.
• allow the investigators to study gene mutation results.
• allow the investigators to perform pharmacogenetic profiling.
• allow the investigators to study pharmacogenetic profiles.
• allow the investigators to examine chromosome copy number variations.
• allow the investigators to examine genomic methylation.
• allow the investigators to quantify metabolomics/cytokines.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • UF Health Shands Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals known or suspected of having a blood cancer or hematologic disorder
• Individuals with presence of extramedullary disease
• Capable of providing informed consent.

Exclusion Criteria:

• Does not have a blood cancer or a hematologic disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acute Myeloid Leukemia; Patients with acute myeloid leukemia will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.	Genetic: Molecular diagnostic testing; Molecular diagnostic testing will be performed on peripheral blood, bone marrow aspirate and saliva samples that will be collected from each patient as part of routine care. Tests performed may include: cytogenetics, FISH, chromosome copy number variation, next generation DNA sequencing, methylation, and metabolomics.
Experimental: Acute Lymphoblastic Leukemia; Patients with acute lymphoblastic leukemia will have blood, bone marrow aspirate , and saliva collected from them as part of routine care.	Genetic: Molecular diagnostic testing; Molecular diagnostic testing will be performed on peripheral blood, bone marrow aspirate and saliva samples that will be collected from each patient as part of routine care. Tests performed may include: cytogenetics, FISH, chromosome copy number variation, next generation DNA sequencing, methylation, and metabolomics.
Experimental: Myelodysplastic Syndrome; Patients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.	Genetic: Molecular diagnostic testing; Molecular diagnostic testing will be performed on peripheral blood, bone marrow aspirate and saliva samples that will be collected from each patient as part of routine care. Tests performed may include: cytogenetics, FISH, chromosome copy number variation, next generation DNA sequencing, methylation, and metabolomics.
Experimental: Myelofibrosis; Patients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.	Genetic: Molecular diagnostic testing; Molecular diagnostic testing will be performed on peripheral blood, bone marrow aspirate and saliva samples that will be collected from each patient as part of routine care. Tests performed may include: cytogenetics, FISH, chromosome copy number variation, next generation DNA sequencing, methylation, and metabolomics.
Experimental: Multiple Myeloma; Patients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.	Genetic: Molecular diagnostic testing; Molecular diagnostic testing will be performed on peripheral blood, bone marrow aspirate and saliva samples that will be collected from each patient as part of routine care. Tests performed may include: cytogenetics, FISH, chromosome copy number variation, next generation DNA sequencing, methylation, and metabolomics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response	The overall response rate (ORR) is defined as achieving a complete remission (CR), partial remission (PR), and/or hematological improvement based on 2006 International Working Group (IWG) criteria (Cheson, et al. Blood 2006).	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with drug-related Grade 3 and Grade 4 adverse events	Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 4. Adverse event incidences will be compared to individual pharmacogenetic gene variants.	Up to 5 years
Progression-free survival after treatment	The disease free survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.	Up to five years
Overall survival after treatment	The overall survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.	Up to 5 years

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Gateway for Cancer Research; Cellworks Group Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2015
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Myelodysplastic Syndromes; Multiple Myeloma; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: IRB201500073; OCR14209 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No