acute promyelocytic leukemia acute promyelocytic leukemia
Conditions
Interventions
1. Induction therapy
All-trans retinoic acid (ATRA) + arsenic trioxide (ATO)
ATRA 45 mg/m2 is administered orally starting on day 1. ATRA is continued until hematological CR or for a maximum of 60 d
For patients with initial white blood cell count > 10,000 /microL, ATO is started from day 5, and idarubicin 12 mg/m2 is added intravenously on days 1, 2.
2. Intrathecal chemotherapy
methotrexate 1
D014212, D000077237
all-trans retinoic acid, arsenic trioxide
Sponsors
Kiyoi Hitoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinically diagnosed, untreated acute promyelocytic leukemia. PML-RARA must be positive or at least under testing by PCR at the time of registration. 2. Patients who have been informed that they have acute promyelocytic leukemia. 3. Age >= 16. 4. ECOG performance status 0 - 2. 5. Sufficient cardiac, pulmonary, hepatic, and renal functions to receive the treatment. The criteria are as follows; Total bilirubin = 50% in echocardiography. PaO2 >= 60 mmHg or SpO2 >= 93% in room air. No severe abnormalities on electrocardiogram. QTc < 500 msec (using QTcF formula). 6. Written informed consent. For patients younger than 20 years, consent of the person in charge is also required. 7. Asian patients.
Exclusion criteria
Exclusion criteria: 1. Extramedullary disease. 2. APL arising from myelodysplastic syndromes, or atypical leukemia. 3. Absence of PML-RARA rearrangement. 4. Uncontrollable infectious diseases including active tuberculosis. 5. Viral infections which require treatment with antivirus agents. Patients with COVID-19 or asymptomatic SARS-CoV-2 infection. Patients wiht herpes simplex which can be controlled by local treatment are not excluded. 6. Severe comorbidities such as malignant hypertension, congestive heart failure, renal failure, hepatic failure, acute myocardial infaction within 3 months before registration, severe arrhythmia, liver cirrosis, severe non-controlled diabetes, pulmonary fibrosis, interstitial pneumonia, active pneumonia under treatment, requirement of oxygen inhalation, gastrointestinal or respiratory tract hemorrhage, etc. 7. Human immunodificiency virus (HIV) infection. Active hepatitis B or C (Inactive carrier is allowed). 8. Other active malignancies. 9. Pregnant or breast-feeding women. 10. Severe psychiatric disease. 11. Patients with contraindications to ATRA or ATO 12. Patients who are considered by the investigator to be ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year EFS with stratification by the risk of APL | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events Incedence of disseminated intravascular coagulation Rate of complete remission 2-year and 3-year EFS, RFS, OS 3-year EFS with stratification by the risk of APL 2-year and 3-year RFS and OS with stratification by the risk of APL 2-year and 3-year EFS, RFS, OS with stratification by age Comparison of 3-year EFS, RFS, OS between the present study and the historical controls (APL-97, -204, -212, -212G) | — |
Contacts
Public ContactYasuhisa Yokoyama
Japan Institute for Health Security National Center for Global Health and Medicine
Outcome results
None listed