Induction of remission and consolidation therapy using ATRA and ATO for acute promyelocytic leukemia - JSCT APL2021 -

JRCT ID: jRCTs071210035

Registered date:18/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute promyelocytic leukemia
• Date of first enrollment: 16/07/2021
• Target sample size: 90
• Study type: Interventional

Intervention(s)

Induction therapy: low-risk group
ATRA 45mg / m2 2-3x po day1-max day 60
After detection of ATO 0.15mg / kg div PML / RARA fusion gene-max day60
Regulate white blood cell count during treatment with hydroxyurea.
Induction therapy: high-risk group
IDR 12mg / m2 day2,4,6,8
ATRA 45mg / m2 2-3x po day1-max day 70
After detection of ATO 0.15mg / kg div PML / RARA fusion gene-max day70
Regulate white blood cell count during treatment with hydroxyurea.
After induction therapy: high-risk group
Intrathecal chemotherapy: MTX 15mg + AraC 20mg + DEX 3.3mg
Consolidation therapy
Take ATRA for 14 days and repeat withdrawal for 14 days twice. ATO is administered 5 days a week with a 2-day rest period. This is repeated for 4 weeks and the drug is withdrawn for 4 weeks. ATO should be administered 20 times within 4 weeks after the start of administration. The above is set as one course (total 8 weeks), and 4 courses are repeated. The 4th course ATRA is taken only for 14 days in the 1st and 2nd weeks.

Outcome(s)

• Primary Outcome: Disease-free survival 2 years after the start of treatment

Secondary Outcome

1) Complete remission rate 2 years after the start of treatment
2) Protocol completion rate
3) Rate of adverse events
4) Differentiation syndrome incidence rate
5) Frequency of additional administration of Idarubicin
6) PML / RARA fusion gene subtypes and therapeutic responsiveness due to gene mutations
7) Analysis of gene expression, protein expression, etc. related to treatment resistance in APL cells

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Takase Ken