AMLNCT01535456
FLT-PET Imaging for MDS
A study testing FLT-PET scans in people with AML and MDS, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The main purpose of this study is to see if this tracer can be used to determine how well chemotherapy is working in patients with certain types of leukemia. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- FLT-PET scans
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Mar 2014
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects with previously untreated, Intermediate-2 or High risk myelodysplastic syndrome are eligible. These patients have an international prognostic scoring system (IPSS) score of 1.5 to 3.5 based on bone marrow blast percentage, karyotype, and the number of cytopenias 26.
- Subjects will receive the standard FDA-approved dose and schedule of 5-azacitidine. This dose is 75mg/m2 SQ or IV daily for seven days with cycles repeated every 28 days
- The subject's treating physician must have an initial intent of treating with at least four cycles of therapy
- Subjects must have an ECOG performance status of 0, 1, or 2
- Subjects must not have been treated with chemotherapy or radiation for another malignancy within the preceding 6 months
- Subjects must be > 18 years of age
Show all 10Show fewer
- Subjects must have a serum creatinine < 2.0 mg/dL and/or calculated GHF 50 ml/min/1.73m (MRDR formula) or greater
- Subjects must have a serum direct bilirubin < 2.0 mg/dL unless related to Gilbert's syndrome of hemolysis. Alkaline phosphatase, SGOT (AST), and SGPT (ALT) must be less than 4 x upper limit of normal
- Women must not be pregnant nor breastfeeding
- Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
Who cannot join
- Subjects who are pregnant or breast feeding
- Subjects for whom a therapy other than 5-azacitidine is recommended as first line treatment.
- Allogeneic stem cell transplantation in patients with a suitable donor, lack of comorbidities, and good performance status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study for Using 18F-FLT PET Imaging To Assess Response In Patients With Myelodysplastic Syndrome (MDS) Being Treated With 5-azacitidine
The main purpose of this study is to see if this tracer can be used to determine how well chemotherapy is working in patients with certain types of leukemia.
Read the detailed description
Primary objectives
- To evaluate if FLT-PET uptake shows variation during the treatment course in subjects with MDS being treated with 5-azacitidine therapy Secondary objectives
- To assess FLT-PET uptake heterogeneity within given subjects being treated with 5-azacitidine therapy
- To generate preliminary data regarding correlation between FLT-PET imaging parameters and clinical responses based on bone marrow aspirate/biopsy
- Being tested
- FLT-PET scans
- Keywords
- MDS, AML, 5 azacitidine, FLT PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLT-PET scansProcedure or surgery
FLT-PET scans prior to treatment, after Cycle 1, after Cycle 4
| Study group | Role | What they receive |
|---|---|---|
| F-FLT PET scan, 5-azacitidine treatment | Experimental | F-FLT Pet scan followed by 5-azacitidine treatment followed by FLT-PET scan. Three additional cycles of 5-azacytidine and follow up FLT-PET scan. Receives: Procedure: FLT-PET scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of using FLT-PET to assess chemotherapy response in AML/MDS
This pilot study is intended to investigate the feasibility of FLT-PET for early assessment of treatment response in myelodysplastic syndrome and the use of a PET isotope, (18)F-FLT, in the imaging of bone marrow in subjects with MDS. The objectives will help gather initial information for a future, larger, more definitive study.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionMar 2014
Why it stopped: funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan J Mattison, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535456
- Sponsor's protocol ID
- HO10417
- Other IDs
- A534260, SMPH\MEDICINE\HEM-ONC, NCI-2012-00362, 2011-0285
- Status last verified
- Apr 2015
- First submitted
- 14 Feb 2012
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Using 18F-FLT PET Imaging To Assess Response In Patients With Myelodysplastic Syndrome (MDS) Being Treated With 5-azacitidine
- ClinicalTrials.gov ID
- NCT01535456
- Acronym / sponsor ID
- HO10417
- Keywords
- MDS, AML, 5 azacitidine, FLT PET
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Feb 2012 (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 main purpose of this study is to see if this tracer can be used to determine how well chemotherapy is working in patients with certain types of leukemia.
Detailed description
Primary objectives
- To evaluate if FLT-PET uptake shows variation during the treatment course in subjects with MDS being treated with 5-azacitidine therapy Secondary objectives
- To assess FLT-PET uptake heterogeneity within given subjects being treated with 5-azacitidine therapy
- To generate preliminary data regarding correlation between FLT-PET imaging parameters and clinical responses based on bone marrow aspirate/biopsy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F-FLT PET scan, 5-azacitidine treatment | Experimental | Procedure: FLT-PET scansF-FLT Pet scan followed by 5-azacitidine treatment followed by FLT-PET scan. Three additional cycles of 5-azacytidine and follow up FLT-PET scan. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All subjects with previously untreated, Intermediate-2 or High risk myelodysplastic syndrome are eligible. These patients have an international prognostic scoring system (IPSS) score of 1.5 to 3.5 based on bone marrow blast percentage, karyotype, and the number of cytopenias 26.
- Subjects will receive the standard FDA-approved dose and schedule of 5-azacitidine. This dose is 75mg/m2 SQ or IV daily for seven days with cycles repeated every 28 days
- The subject's treating physician must have an initial intent of treating with at least four cycles of therapy
- Subjects must have an ECOG performance status of 0, 1, or 2
- Subjects must not have been treated with chemotherapy or radiation for another malignancy within the preceding 6 months
Key exclusion criteria (3 listed)
- Subjects who are pregnant or breast feeding
- Subjects for whom a therapy other than 5-azacitidine is recommended as first line treatment.
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 |
|---|---|---|
| FLT-PET scansFLT-PET scans prior to treatment, after Cycle 1, after Cycle 4 | Procedure or surgery | F-FLT PET scan, 5-azacitidine treatment |
Primary outcome
feasibility of using FLT-PET to assess chemotherapy response in AML/MDS
Time frame: 3 years
This pilot study is intended to investigate the feasibility of FLT-PET for early assessment of treatment response in myelodysplastic syndrome and the use of a PET isotope, (18)F-FLT, in the imaging of bone marrow in subjects with MDS. The objectives will help gather initial information for a future, larger, more definitive study.
Results and safety
The study was stopped early (reason given: funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
Related trials for AML
RecruitingObservational study
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Hematologic Malignancy, Leukemia
Not yet recruiting
my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
Sarcoma, Osteosarcoma
RecruitingPhase 1/2
CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
RecruitingPhase 1
A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS
Acute Myeloid Leukemia Refractory, Myelodysplastic Syndrome Acute Myeloid Leukemia
Recruiting
Involvement of CDA and/or dCK Metabolizing Enzymes in the Response to Azacytidine Treatment of Patients With Hematologic Malignancies
Myelodysplastic Syndromes (MDS), Leukemia Acute Myeloid - AML
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.
Ryan J Mattison, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLT-PET scans in people with AML and MDS, run by University of Wisconsin, Madison 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 10 inclusion and 3 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 13 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: funding). 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?
feasibility of using FLT-PET to assess chemotherapy response in AML/MDS (time frame: 3 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 13 Dec 2019; AzTrials last refreshed its copy on 31 Oct 2026.