Myelodysplastic SyndromesNCT02435550
iCare for Cancer Patients
A study testing Molecular diagnostic testing in people with Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Acute Myelogenous Leukemia
- What is being tested?
- Molecular diagnostic testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2015to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals known or suspected of having a blood cancer or hematologic disorder
- Individuals with presence of extramedullary disease
- Capable of providing informed consent.
Who cannot join
- Does not have a blood cancer or a hematologic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Shands Cancer Hospital
Gainesville, Florida, 32608
About this study
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.
Read the 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.
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Acute Myelogenous Leukemia, Acute Lymphoid Leukemia, Leukemia, Acute Lymphoblastic, Multiple Myeloma
- Being tested
- Molecular diagnostic testing
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Multiple Myeloma, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular diagnostic testingGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute Myeloid Leukemia | Experimental | Patients with acute myeloid leukemia will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. Receives: Genetic: Molecular diagnostic testing |
| Acute Lymphoblastic Leukemia | Experimental | Patients with acute lymphoblastic leukemia will have blood, bone marrow aspirate , and saliva collected from them as part of routine care. Receives: Genetic: Molecular diagnostic testing |
| Myelodysplastic Syndrome | Experimental | Patients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. Receives: Genetic: Molecular diagnostic testing |
| Myelofibrosis | Experimental | Patients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. Receives: Genetic: Molecular diagnostic testing |
| Multiple Myeloma | Experimental | Patients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. Receives: Genetic: Molecular diagnostic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 5 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study start26 Jun 2015
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Why it stopped: Halted due to funding issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Cellworks Group Inc., Gateway for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Christopher R. Cogle, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435550
- Sponsor's protocol ID
- IRB201500073
- Other IDs
- OCR14209
- Status last verified
- Dec 2019
- First submitted
- 20 Apr 2015
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCare for Cancer Patients
- ClinicalTrials.gov ID
- NCT02435550
- Acronym / sponsor ID
- IRB201500073
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Acute Myelogenous Leukemia, Acute Lymphoid Leukemia, Leukemia, Acute Lymphoblastic, Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted due to funding issues.
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Cellworks Group Inc., Gateway for Cancer Research
- Study start
- 26 Jun 2015 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Acute Myeloid Leukemia | Experimental | Genetic: Molecular diagnostic testingPatients with acute myeloid leukemia will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. |
| Acute Lymphoblastic Leukemia | Experimental | Genetic: Molecular diagnostic testingPatients with acute lymphoblastic leukemia will have blood, bone marrow aspirate , and saliva collected from them as part of routine care. |
| Myelodysplastic Syndrome | Experimental | Genetic: Molecular diagnostic testingPatients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. |
| Myelofibrosis | Experimental | Genetic: Molecular diagnostic testingPatients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. |
| Multiple Myeloma | Experimental | Genetic: Molecular diagnostic testingPatients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals known or suspected of having a blood cancer or hematologic disorder
- Individuals with presence of extramedullary disease
- Capable of providing informed consent.
Key exclusion criteria (1 listed)
- Does not have a blood cancer or a hematologic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular diagnostic testingMolecular 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. | Genetic | Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Multiple Myeloma, Myelodysplastic Syndrome, Myelofibrosis |
Primary outcome
Overall Response
Time frame: 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).
3 secondary outcomes
Number of patients with drug-related Grade 3 and Grade 4 adverse events
Time frame: Up to 5 years
Progression-free survival after treatment
Time frame: Up to five years
Overall survival after treatment
Time frame: Up to 5 years
Results and safety
The study was stopped early (reason given: Halted due to funding issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher R. Cogle, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular diagnostic testing in people with Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Halted due to funding issues.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019; AzTrials last refreshed its copy on 29 Oct 2026.