Phase III Study of Vincristine Sulfate Liposome For Injection In Adults With Naïve Acute Lymphoblastic Leukemia

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.

Conditions

• Adult Acute Lymphoblastic Leukemia

Interventions

DRUG

Vincristine Sulfate Liposome

DRUG

Vincristine Sulfate

Sponsors & Collaborators

• Ethics Committee of Blood Diseases Hospital

  collaborator UNKNOWN

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• Xinqiao Hospital of Chongqing

  collaborator OTHER

• China Medical University, China

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Xuzhou Medical University

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Nanjing Luye Sike Pharmaceutical Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2017-02-28

Completion

2017-02-28

Countries

• China

Study Locations