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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary: In this prospective randomized study for patients with newly diagnosed acute promyelocytic leukemia. For induction, all patients will be randomized into two groups which received treatment composed of retinoic acid combined with arsenic trioxide versus retinoic acid combined with chemotherapy. For consolidation, the experimental group recieved 2 cycles of ATRA+arsenic and control group recieved two cycles of ATRA+idarubicin or daunorubicin. After consolidation, all patients achieved molecular remission will recieved 5 cycles of maintenance treatment with ATRA and arsenic. In case of intermediate or high-risk disease, cytarabine will be add for consolidation.
Sponsor: Shanghai Jiao Tong University School of Medicine

Current Primary Outcome: disease free survival [ Time Frame: 3 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: overall survival [ Time Frame: 3 year ]

Original Secondary Outcome: Same as current

Information By: Shanghai Jiao Tong University School of Medicine

Dates:
Date Received: December 6, 2012
Date Started: October 2012
Date Completion: October 2017
Last Updated: May 9, 2016
Last Verified: May 2016