iCare for Cancer Patients

Not Applicable

Terminated

• Conditions: Acute Lymphoid Leukemia; Leukemia, Acute Lymphoblastic; Multiple Myeloma; Acute Myeloid Leukemia; Acute Myelogenous Leukemia; Myelofibrosis; Myelodysplastic Syndromes
• Interventions: Genetic: Molecular diagnostic testing

• Registration Number: NCT02435550
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-06
• Study Start: 2015-06-26
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 136

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.

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Exclusion Criteria

• Does not have a blood cancer or a hematologic disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acute Lymphoblastic Leukemia	Molecular diagnostic testing	Patients with acute lymphoblastic leukemia will have blood, bone marrow aspirate , and saliva collected from them as part of routine care.
Myelofibrosis	Molecular diagnostic testing	Patients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
Acute Myeloid Leukemia	Molecular diagnostic testing	Patients with acute myeloid leukemia will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
Myelodysplastic Syndrome	Molecular diagnostic testing	Patients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.
Multiple Myeloma	Molecular diagnostic testing	Patients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.

Primary Outcome Measures

Name	Time	Method
Overall Response	Up to 5 years	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

Name	Time	Method
Overall survival after treatment	Up to 5 years	The overall survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.
Number of patients with drug-related Grade 3 and Grade 4 adverse events	Up to 5 years	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	Up to five years	The disease free survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.

Trial Locations

Locations (1)

UF Health Shands Cancer Hospital; 🇺🇸 Gainesville, Florida, United States