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iCare for Cancer Patients

Primary Purpose

Myelodysplastic Syndromes, Acute Myeloid Leukemia, Acute Myelogenous Leukemia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Molecular diagnostic testing
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myelodysplastic Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UF Health Shands Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Myelodysplastic Syndrome

Myelofibrosis

Multiple Myeloma

Arm Description

Patients with acute myeloid leukemia will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.

Patients with acute lymphoblastic leukemia will have blood, bone marrow aspirate , and saliva collected from them as part of routine care.

Patients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.

Patients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.

Patients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Progression-free survival after treatment
The disease free survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.
Overall survival after treatment
The overall survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.

Full Information

First Posted
April 20, 2015
Last Updated
December 18, 2019
Sponsor
University of Florida
Collaborators
Cellworks Group Inc., Gateway for Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT02435550
Brief Title
iCare for Cancer Patients
Official Title
iCare for Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Halted due to funding issues.
Study Start Date
June 26, 2015 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Cellworks Group Inc., Gateway for Cancer Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes, Acute Myeloid Leukemia, Acute Myelogenous Leukemia, Acute Lymphoid Leukemia, Leukemia, Acute Lymphoblastic, Multiple Myeloma, Myelofibrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute Myeloid Leukemia
Arm Type
Experimental
Arm Description
Patients with acute myeloid leukemia will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
Arm Title
Acute Lymphoblastic Leukemia
Arm Type
Experimental
Arm Description
Patients with acute lymphoblastic leukemia will have blood, bone marrow aspirate , and saliva collected from them as part of routine care.
Arm Title
Myelodysplastic Syndrome
Arm Type
Experimental
Arm Description
Patients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
Arm Title
Myelofibrosis
Arm Type
Experimental
Arm Description
Patients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
Arm Title
Multiple Myeloma
Arm Type
Experimental
Arm Description
Patients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
Intervention Type
Genetic
Intervention Name(s)
Molecular diagnostic testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Response
Description
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).
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Number of patients with drug-related Grade 3 and Grade 4 adverse events
Description
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.
Time Frame
Up to 5 years
Title
Progression-free survival after treatment
Description
The disease free survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.
Time Frame
Up to five years
Title
Overall survival after treatment
Description
The overall survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher R. Cogle, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health Shands Cancer Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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