Combined Retinoic Acid,Arsenic Trioxide and Chemo for Newly-diagnosed APL

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In this prospective randomized study for patients with newly diagnosed acute promyelocytic leukemia, patients will be randomized (1:1) into two groups which receive retinoic acid and arsenic trioxide based treatment versus retinoic acid and chemotherapy based regimen.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: First Affiliated Hospital of Guangxi Medical University; First Affiliated Hospital of Zhejiang University; First Affiliated Hospital, Sun Yat-Sen University; First Hospital of China Medical University; Guangdong Provincial People's Hospital; Institute of Hematology & Blood Diseases Hospital; Nanfang Hospital of Southern Medical University; Ningbo No. 1 Hospital; Peking University People's Hospital; Qilu Hospital of Shandong University; Shandong Provincial Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Southwest Hospital, China; Tang-Du Hospital; The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Soochow University; The First Affiliated Hospital with Nanjing Medical University; The Second Affiliated Hospital of Dalian Medical University; Tongji Hospital; Union hospital of Fujian Medical University; West China Hospital; Wuhan Union Hospital, China
• Treatments: Arsenic Trioxide; Cytarabine; Daunorubicin; Idarubicin; Tretinoin

Criteria

Inclusion Criteria:

• Newly-diagnosed patients with acute promyelocytic leukemia via cytogenetics and molecular assay

• Age: 18-65

• Hepatic/renal function: Bil≤35μmol/L，AST/ALT less than 2Xnormal range, Cr 150μmol/L

• Normal cardial function

• ECOG：0-4

• Informed consent

Exclusion Criteria:

• QTC interval >450ms

• Pregnant or breast feeding patients

• Patients with drug addiction or mental illness

• Patients documented of CNS infiltration at diagnosis

• Patients with severe heart disease (acute myocardial infarction or heart failure)

• Patients with concurrent active malignancy, tuberculosis or HIV infection

• Patients with contraindication or allergy to anthracyclines or other agent in the protocol

• Patients enrolled in other clinical trials

• Patients not apply to the study protocol