Acute Myeloid LeukemiaNCT02156297
Sorafenib to Treat FLT3-ITD AML
An observational study of Acute Myeloid Leukemia and FLT3-ITD Mutation, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
It is a prospective, non-interventional, open-label study, in order to observe the safety and response in FLT3-ITD mutation positive AML patients who receiving sorafenib as induction, consolidation, salvage, maintenance or alleviative treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, FLT3-ITD Mutation
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Aug 2022
- Phase
- Observational
- 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
Study population: Patients who diagnosed as AML with FLT3-ITD mutation and accepting the prescription of sorafenib.
Who may be able to join
- Definitely diagnosed as AML
- FLT3-ITD mutation has been confirmed
- Accepting the prescription of sorafenib
Who cannot join
- Can not take drugs orally
- Can not follow the doctors' advices
- Other reasons that investigators considered as contra-indications for this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Jia Chen, M.D., +86 512 67781856, c_jerry_j@163.com
Depei Wu, M.D., Ph.D.
About this study
Official title: Sorafenib to Treat AML Patients With FLT3-ITD Mutation: a Non-interventional Cohort Study
It is a prospective, non-interventional, open-label study, in order to observe the safety and response in FLT3-ITD mutation positive AML patients who receiving sorafenib as induction, consolidation, salvage, maintenance or alleviative treatment. The duration of the study from June 2014 through May 2019, with the recruitment duration from June 2014 to May 2017. The inclusion criteria is:
- Definitely diagnosed as AML
- FLT3-ITD mutation has been confirmed
- Accepting the prescription of sorafenib
- Conditions
- Acute Myeloid Leukemia, FLT3-ITD Mutation
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Induction Group | Not described | |
| Consolidation Group | Not described | |
| Salvage Group | Not described | |
| Maintenance Group | Not described | |
| Alleviatitive Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Measured: up to 2 years
Progress-Free Survival
Measured: up to 2 years
Secondary outcomes (3)
Overall Survival
Measured: up to 2 years
Leukemia-Free Survival
Measured: up to 2 years
Median time to the onset of sorafenib resistance
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2020 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156297
- Sponsor's protocol ID
- SZ3201
- Status last verified
- Feb 2020
- First submitted
- 30 May 2014
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sorafenib to Treat AML Patients With FLT3-ITD Mutation: a Non-interventional Cohort Study
- ClinicalTrials.gov ID
- NCT02156297
- Acronym / sponsor ID
- SZ3201
- Conditions
- Acute Myeloid Leukemia, FLT3-ITD Mutation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2020 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 5 Jun 2014 (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.
It is a prospective, non-interventional, open-label study, in order to observe the safety and response in FLT3-ITD mutation positive AML patients who receiving sorafenib as induction, consolidation, salvage, maintenance or alleviative treatment. The duration of the study from June 2014 through May 2019, with the recruitment duration from June 2014 to May 2017. The inclusion criteria is:
- Definitely diagnosed as AML
- FLT3-ITD mutation has been confirmed
- Accepting the prescription of sorafenib
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Induction Group | – | – |
| Consolidation Group | – | – |
| Salvage Group | – | – |
| Maintenance Group | – | – |
| Alleviatitive Group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who diagnosed as AML with FLT3-ITD mutation and accepting the prescription of sorafenib.
Key inclusion criteria (3 listed)
- Definitely diagnosed as AML
- FLT3-ITD mutation has been confirmed
- Accepting the prescription of sorafenib
Key exclusion criteria (3 listed)
- Can not take drugs orally
- Can not follow the doctors' advices
- Other reasons that investigators considered as contra-indications for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Response Rate
Time frame: up to 2 years
Progress-Free Survival
Time frame: up to 2 years
3 secondary outcomes
Overall Survival
Time frame: up to 2 years
Leukemia-Free Survival
Time frame: up to 2 years
Median time to the onset of sorafenib resistance
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and FLT3-ITD Mutation, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Chen, M.D. (+86 512 67781856, c_jerry_j@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: up to 2 years). The study lists 2 primary outcomes in all. 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 5 Feb 2020.