Acute Myeloid Leukemia Clinical Trial
Official title:
Sorafenib to Treat AML Patients With FLT3-ITD Mutation: a Non-interventional Cohort Study
| NCT number | NCT02156297 |
| Other study ID # | SZ3201 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2014 |
| Est. completion date | August 2022 |
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:
1. Definitely diagnosed as AML
2. FLT3-ITD mutation has been confirmed
3. Accepting the prescription of sorafenib
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | August 2022 |
| Est. primary completion date | May 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Definitely diagnosed as AML - FLT3-ITD mutation has been confirmed - Accepting the prescription of sorafenib Exclusion Criteria: - Can not take drugs orally - Can not follow the doctors' advices - Other reasons that investigators considered as contra-indications for this study |
| Country | Name | City | State |
|---|---|---|---|
| China | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| The First Affiliated Hospital of Soochow University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Response Rate | up to 2 years | ||
| Primary | Progress-Free Survival | up to 2 years | ||
| Secondary | Overall Survival | up to 2 years | ||
| Secondary | Leukemia-Free Survival | up to 2 years | ||
| Secondary | Median time to the onset of sorafenib resistance | up to 2 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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