Induction of remission and consolidation therapy using ATRA and ATO for acute promyelocytic leukemia - JSCT APL2021
- Conditions
- Acute promyelocytic leukemia
- Registration Number
- JPRN-jRCTs071210035
- Lead Sponsor
- Takase Ken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
1) Acute promyelocytic leukemia (APL) cases morphologically diagnosed as AML M3 or AML M3 variant.
2) Initial treatment cases not receiving chemotherapy and radiation therapy.
3) Cases aged between 15 and 75 years old at the time of obtaining consent.
4) Perfomance status (ECOG): 0 to 2 cases.
5) Cases that are expected to survive for 3 months or longer.
6) Cases without serious organ damage.
7) Cases in which written consent has been obtained from the patient after explaining the content of this study. However, in the case of minors, cases in which written consent has been obtained from the substitute and the person.
1) Cases with active double cancer.
2) Cases with infectious diseases that are difficult to control.
3) Cases with severe mental disorders.
4) Cases of pregnancy or ongoing lactation.
5) In addition, cases that the doctor in charge judged to be inappropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival 2 years after the start of treatment
- Secondary Outcome Measures
Name Time Method 1) Complete remission rate 2 years after the start of treatment<br>2) Protocol completion rate<br>3) Rate of adverse events<br>4) Differentiation syndrome incidence rate<br>5) Frequency of additional administration of Idarubicin<br>6) PML / RARA fusion gene subtypes and therapeutic responsiveness due to gene mutations<br>7) Analysis of gene expression, protein expression, etc. related to treatment resistance in APL cells