Acute Lymphoid Leukemia, Acute Myelogenous Leukemia, Acute Myeloid Leukemia, Leukemia, Acute Lymphoblastic, Multiple Myeloma, Myelodysplastic Syndromes, Myelofibrosis
Conditions
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.
Interventions
GENETICMolecular 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.
Sponsors
Cellworks Group Inc.
Gateway for Cancer Research
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed