drugset / Trial / NCT01987297
Combined Retinoic Acid,Arsenic Trioxide and Chemo for Newly-diagnosed APL
Phase 4
Unknown
738 enrolled
Shanghai Jiao Tong University School of Medicine
First Affiliated Hospital of Guangxi Medical University · collabFirst Affiliated Hospital of Zhejiang University · collabFirst Affiliated Hospital, Sun Yat-Sen University · collabFirst Hospital of China Medical University · collabGuangdong Provincial People's Hospital · collabInstitute of Hematology & Blood Diseases Hospital, China · collabNanfang Hospital, Southern Medical University · collabNingbo No. 1 Hospital · collabPeking University People's Hospital · collabQilu Hospital of Shandong University · collabShandong Provincial Hospital · collabSouthwest Hospital, China · collabTang-Du Hospital · collabThe First Affiliated Hospital of Anhui Medical University · collabThe First Affiliated Hospital of Soochow University · collabThe First Affiliated Hospital with Nanjing Medical University · collabThe Second Affiliated Hospital of Dalian Medical University · collabTongji Hospital · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabUnion hospital of Fujian Medical University · collabWest 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
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 | Small molecule | 25 mg/m2 | Oral |