Post remission therapy including arsenic trioxide against acute promylocytic leukemia (APL) in elderly patients. (JALSG APL212G study)

JRCT ID: jRCTs041180099

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Adult acute promylocytic leukemia
• Date of first enrollment: 20/10/2012
• Target sample size: 63
• Study type: Interventional

Intervention(s)

Induction therapy consists of ATRA and chemotherapy whose dose and duration were based on initial white blood cell (WBC) count. Patients who achieve hematological remission are treated with 2 courses of consolidation therapy consist of arsenic trioxide. Patients who achieved molecular remission after consolidation therapy were received maintenance therapy with tamibarotene.
Consolidation and maintenance therapies are composed of single arm.

Outcome(s)

• Primary Outcome: 3-year event free survival (EFS)

Secondary Outcome

1. Complete remission rate (CR)
2. 3- and 5-year disease free survival (DFS)of patients in CR
3. 3- and 5-year overall survival (OS)
4. 5-year event free survival (EFS)
5. CR, DFS and OS of each group
6. Adverse events.
7. Analyses of PML-RARA isoform, FLT3/ITD mutation, CD56 expression, additional chromosome abnormality and their effects on prognosis
8. Coagulation and fibrinolysis factors, and their effects on prognosis.
9. Quality of life
10. Determination of genetic abnormality and polymorphism of by genome and exome analyses for treatment related adverse events including APL differentiation syndrome.
11. Determination of genetic abnormality and polymorphism of by genome and exome analyses for the efficacy of treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Newly diagnosed APL (FAB:M3 or M3v)
2. Performance status (ECOG):0-2
3. Adequate cardiac, pulmonary, hepatic and renal function
4. Written informed consent

Exclude criteria

1. History of myelodysplastic syndrome
2. Atypical acute leukemia
3. Uncontrollable infection
4. Severe co-morbidity
5. Positive anti-HIV antibody, HBs antigen or anti-HCV antibody
6. Other active neoplasm
7. Pregnant and/or lactating woman
8. Psychological disorders
9. Patients who have a difficulty to enter the study.

Related Information

• Primary Sponsor: Takeshita Akihiro
• Source(s) of Monetary Support: The Nonprofit Supportive Organization for Cooperative Study on Adult Leukemia Treatment
• Secondary ID(s): UMIN000008471