Treatment protocol for APL

JRCT ID: jRCTs071180040

Registered date:13/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Acute promyelocytic leukemia
• Date of first enrollment: 07/03/2017
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Induction:ATRA 45mg/m2 2-3x po day1-max day74
Consolidation:ATO 0.15mg/kg div day15-max day74
High risk:Intrathecal chemotherapy:MTX 15mg + AraC 20mg + DEX 3.3mg

Outcome(s)

• Primary Outcome: 3 years disease-free survival

Secondary Outcome

5 years disease free survival
CR rate
Perfection rate of protocol regimen
treatment-related toxicities
Incidence rate of differentiation syndrome
Frequency of additional administration of idarubicune
Frequency of mutation in PML-RARA fusion gene and its influence for therapy efficacy

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Acute promyelocytic leukemia by WHO classification
2. The first time treatment example which does not catch chemotherapy or the radiotherapy
3. The case that is equal to or less than 80 years old more than age 15 years old
4. Performance status 0-2
5. A case without the dangerously ill internal organs disorder
6. The case that an agreement by the document is provided from a patient on explanation because of final examination contents

Exclude criteria

1. The case having double cancers
2. The case with an infectious disease having difficulty with control
3. The case with a severe mental disorder
4. The pregnancy or breast-feeding woman
5. The case that the medical attendant judged to be inappropriate

Related Information

• Primary Sponsor: Takase Ken
• Secondary Sponsor: Akashi Koichi
• Source(s) of Monetary Support: The Reg ional Medicine Research Foundation
• Secondary ID(s): UMIN000025044