Combined Retinoic Acid,Arsenic Trioxide and Chemotherapy for Newly-diagnosed Acute Promyelocytic Leukemia: Chinese National Multi-center Randomized Study

NCT01987297 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Shanghai Jiao Tong University School of Medicine
Phase	Phase 4
Status	UNKNOWN
Enrolment	738
Start date	2012-06
Completion	2020-12-31

Conditions

• Acute Promyelocytic Leukemia

Interventions

• ATRA+Arsenic
• ATRA+Chemo

Primary outcomes

• Disease free survival (DFS) — 3 year
  DFS is defined for patients having achieve CR as time to relapse either in bone marrow or extra medullary site, or fail to achieve molecular remission, or death of all causes.

Countries

China