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

NCT01987297 ↗

Phase 4 Unknown 738 enrolled Shanghai Jiao Tong University School of Medicine First Affiliated Hospital of Guangxi Medical University · collab First Affiliated Hospital of Zhejiang University · collab First Affiliated Hospital, Sun Yat-Sen University · collab First Hospital of China Medical University · collab Guangdong Provincial People's Hospital · collab Institute of Hematology & Blood Diseases Hospital, China · collab Nanfang Hospital, Southern Medical University · collab Ningbo No. 1 Hospital · collab Peking University People's Hospital · collab Qilu Hospital of Shandong University · collab Shandong Provincial Hospital · collab Southwest Hospital, China · collab Tang-Du Hospital · collab The First Affiliated Hospital of Anhui Medical University · collab The First Affiliated Hospital of Soochow University · collab The First Affiliated Hospital with Nanjing Medical University · collab The Second Affiliated Hospital of Dalian Medical University · collab Tongji Hospital · collab Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · collab Union hospital of Fujian Medical University · collab West China Hospital · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2012-06
Primary completion: 2020-12-31
Completion: 2020-12-31

Outcome

Met primary endpoint

paper The difference was 3.45% (95% CI -0.07 to 6.97), confirming noninferiority (P < 0.001). PMID 33495363 ↗

Publications

Chen L, Zhu HM, Li Y, Liu QF, Hu Y, Zhou JF, Jin J, Hu JD, Liu T, Wu DP, Chen JP, Lai YR, Wang JX, Li J, Li JY, Du X, Wang X, Yang MZ, Yan JS, Ouyang GF, Liu L, Hou M, Huang XJ, Yan XJ, Xu D, Li WM, Li DJ, Lou YJ, Wu ZJ, Niu T, Wang Y, Li XY, You JH, Zhao HJ, Chen Y, Shen Y, Chen QS, Chen Y, Li J, Wang BS, Zhao WL, Mi JQ, Wang KK, Hu J, Chen Z, Chen SJ, Li JM. Arsenic trioxide replacing or reducing chemotherapy in consolidation therapy for acute promyelocytic leukemia (APL2012 trial). Proc Natl Acad Sci U S A. 2021 Feb 9;118(6):e2020382118. doi: 10.1073/pnas.2020382118.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cytarabine	Small molecule	150 mg/m2	—
Subject	Daunorubicin	Small molecule	45 mg/m2	—
Subject	Idarubicin	Small molecule	8 mg/m2	—
Subject	arsenic trioxide	Small molecule	0.16 mg/kg	Intravenous
Background	Methotrexate	Small molecule	15 mg/m2	—
Background	Tretinoin	Unknown	25 mg/m2	Oral