AML-P13

JRCT ID: jRCTs051180191

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Acute promyelocytic leukemia
• Date of first enrollment: 29/01/2015
• Target sample size: 30
• Study type: Interventional
• Intervention(s): To evaluate an efficacy and safety of the treatment strategy consisted of 2 courses of multi-agent chemotherapy followed by 3 courses of consolidation therapy with either ATO and/or GO.

Outcome(s)

• Primary Outcome: Three-year event-free survival rate

Secondary Outcome

Remission induction rate
Molecular remission rate at the end of consolidation therapy
Three-year overall survival rate
Rate of DIC, APL-DS, and mortality during first remission induction therapy
Rate of adverse events during ATO therapy
Rate of adverse events

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 18age old
• Gender: Both

Include criteria

Patient with a diagnosis of APL genetically or cytogenetically diagnosed by either one of three methods; karyotyping, FISH, or RT-PCR.
ECOG performance status score of 0-2, or of 3 when caused by leukemia.
No previous treatment.
Written informed consent obtained either from patient or guardians.

Exclude criteria

17q12/RARA not detected genetically and cytogenetically
APL with t(11;17)(q23;q12)/PLZF-RARA
CNS hemorrhage which is likely to interfere protocol therapy
Secondary APL due to previous chemotherapy or radiation therapy
Unmanageable infectious disease including tuberculosis
Any inappropriate status judged by physician

Related Information

• Primary Sponsor: TAKAHASHI Hiroyuki
• Secondary ID(s): UMIN000015348