Post remission therapy with arsenic trioxide and gemtuzumab ozogamicin in acute promylocytic leukemia (JALSG APL212)

JRCT ID: jRCTs041180100

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: 28/08/2012
• Target sample size: 222
• 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 4 courses of consolidation therapy:
arsenic trioxide for the first and the third course; daunorubicin and cytosine arabinoside for the second course; and gemtuzumab ozogamicin for the forth course. Patients who achieve molecular remission after consolidation therapy are received maintenance therapy with tamibarotene.
Consolidation and maintenance 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. Determination of genetic abnormality and polymorphism of by genome and exome analyses for treatment related adverse events including APL differentiation syndrome.
10. Determination of genetic abnormality and polymorphism of by genome and exome analyses for the efficacy of treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 64age old
• 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): UMIN000008470