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

• Status: Unknown status
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing Luye Sike Pharmaceutical Co., Ltd.; Nanjing Luye Sike Pharmaceutical Co.,Ltd.
• Collaborators: China Medical University, China; Ethics Committee of Blood Diseases Hospital; First Affiliated Hospital of Harbin Medical University; First Affiliated Hospital of Zhejiang University; Guangdong General Hospital; Guangdong Provincial People's Hospital; Nanfang Hospital of Southern Medical University; Qilu Hospital; Qilu Hospital of Shandong University; Second Affiliated Hospital of Xi'an Jiaotong University; The First Affiliated Hospital of Zhengzhou University; The Second Hospital of Hebei Medical University; West China Hospital; Xijing Hospital; Xinqiao Hospital of Chongqing; Xuzhou Medical University
• Treatments: Vincristine

Criteria

Inclusion Criteria:

• De novo untreated ALL patients diagnosed by the bone marrow morphology, immunophenotype.

• 65 ≥ Age (years) ≥ 18 , male or female,

• ECOG Performance status of 0, 1, or 2.

• Patients must fulfill the following laboratory values

1. Total bilirubin ≤2 ULN (corrected for same age)

2. AST and ALT ≤3 ULN ( corrected for same ages)

3. Serum creatinine ≤2 ULN (corrected for same age)

• Didn't receive any of the following treatments within 4 weeks before inclusion:

chemotherapy, radiotherapy, replacement therapy, operation, long term of glucocorticoid therapy（>5 days）.

• No neurological disorders, no nerve or muscle injury (motor and sensory nerve).

• Patient must sign the informed consent and obey the protocol.

Exclusion Criteria:

• Atopy or allergic to multiple medicines or excipients.

• With serious complications that affect compliance.

• Serious organ dysfunctions or central nervous system disorders.

• Mixed phenotype acute leukemia, (T-B).

• Burkitt lymphoma/leukemia.

• Suspected or confirmed central nervous system leukemia.

• Diabetes.

• Received antifungal treatment with triazole agents within 1 month before inclusion.

• Reliance of antipyretic and analgesic medicines or psychotropic medicines.

• Undergoing or has undergone other clinical trials in 4 weeks before inclusion.

• Pregnant women, women of breast feeding or childbearing potential without contraception.

• Psychological disorders that affect signing consent.

• The investigators believe that patients who are not suitable for inclusion.