Multicenter, phase II study of arsenic trioxide and all-trans retinoic acid in patients with newly diagnosed acute promyelocytic leukemia in Japan (JALSG-APL220)
- Conditions
- acute promyelocytic leukemiaD015473
- Registration Number
- JPRN-jRCTs041200102
- Lead Sponsor
- Yokoyama Yasuhisa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 99
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 < 2.0 mg/dL.
Serum creatinine < 2.0 mg/dL.
Cardiothoracic ratio <= 50% on a P-A chest X-ray. In case of cardiomegaly, LVEF >= 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year EFS with stratification by the risk of AP
- Secondary Outcome Measures
Name Time Method Incidence of adverse events<br>Incedence of disseminated intravascular coagulation<br>Rate of complete remission<br>2-year and 3-year EFS, RFS, OS<br>3-year EFS with stratification by the risk of APL<br>2-year and 3-year RFS and OS with stratification by the risk of APL<br>2-year and 3-year EFS, RFS, OS with stratification by age<br>Comparison of 3-year EFS, RFS, OS between the present study and the historical controls (APL-97, -204, -212, -212G)