Multicenter, phase II study of arsenic trioxide and all-trans retinoic acid in patients with newly diagnosed acute promyelocytic leukemia in Japan (JALSG-APL220) - JALSG-APL220

Yokoyama Yasuhisa0 个研究点目标入组 99 人开始时间: 2021年2月15日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•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.

发起方

Yokoyama Yasuhisa