drugset / Trial / NCT02072785
Phase III Study of Vincristine Sulfate Liposome For Injection In Adults With Naïve Acute Lymphoblastic Leukemia
Phase 3
Unknown
480 enrolled
Nanjing Luye Sike Pharmaceutical Co., Ltd.
China Medical University, China · collabEthics Committee of Blood Diseases Hospital · collabFirst Affiliated Hospital of Harbin Medical University · collabFirst Affiliated Hospital of Zhejiang University · collabGuangdong Provincial People's Hospital · collabNanfang Hospital, Southern Medical University · collabQilu Hospital of Shandong University · collabSecond Affiliated Hospital of Xi'an Jiaotong University · collabThe First Affiliated Hospital of Zhengzhou University · collabThe Second Hospital of Hebei Medical University · collabWest China Hospital · collabXijing Hospital · collabXinqiao Hospital of Chongqing · collabXuzhou Medical University · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine whether vincristine sulfate liposome could reduce less peripheral neuropathy than vincristine sulfate,and be as effective as vincristine sulfate in adults with Naïve Acute Lymphoblastic Leukemia.
Timeline
- Start
- 2013-06
- Primary completion
- 2017-02
- Completion
- 2017-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |