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

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.

Conditions

• Acute Promyelocytic Leukemia

Interventions

DRUG

ATRA+Arsenic

ATRA: 25mg/m2 daily；Induction: D1 to CR; Consolidation: D1-14 each course; Maintenance: D1-14 each course. Arsenic: 0.16mg/kg daily. Induction: D1 to CR; Consolidation: low/intermediate-risk patients 28 days each course; high-risk: 14 days each course; Maintenance: 14 days on and off each course. Idarubicin 8mg/m2 or Daunorubicin 45mg/m2 daily. Induction: 3-4 days in high-risk patients or intermediated-risk patients with leukocytosis developed during induction therapy. Consolidation: 3 days in high-risk patients in first 2 courses. MTX: 15mg/m2 qw Maintenance: qw x 4 in each course for high-risk patients.

DRUG

ATRA+Chemo

ATRA: 25mg/m2 daily；Induction: D1 to CR; Consolidation: D1-14 each course; Maintenance: D1-14 each course. Arsenic: 0.16mg/kg daily. Induction: D1 to CR; Maintenance: 14 days on and off each course. Idarubicin 8mg/m2 or Daunorubicin 45mg/m2 daily. Induction: 3-4 days in high-risk patients or intermediated-risk patients with leukocytosis developed during induction therapy. Consolidation: 3 days in all patients in 2 courses. Cytarabine: 150mg/m2 or 1g/m2. Consolidation: 150mg/m2 daily x 7 days in high risk patients in first 2 courses; 1g/m2 q12 x 6 doses in third course. MTX: 15mg/m2 qw Maintenance: qw x4 in each course for high-risk patients.

Sponsors & Collaborators

• Tang-Du Hospital

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Ningbo No. 1 Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Union hospital of Fujian Medical University

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Institute of Hematology & Blood Diseases Hospital, China

  collaborator OTHER

• Shanghai Jiao Tong University School of Medicine

  lead OTHER

Principal Investigators

• Jun-min Li, M.D · Department of Hematology, Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• China

Study Locations