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

Adult Acute Lymphoblastic Leukemia Clinical Trial

— LY01609  

Official title:

Phase III Study of Vincristine Sulfate Liposome Or Vincristine Sulfate For Injection Combined Chemotherapy as Initial Induction Regimen In Adults Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02072785
• Other study ID #: LUYESIKE-VSL-?-01
• Status: Recruiting
• Phase: Phase 3
• First received: February 25, 2014
• Last updated: February 27, 2014
• Start date: June 2013
• Est. completion date: February 2017

Study information

• Verified date: November 2013
• Source: Nanjing Luye Sike Pharmaceutical Co.,Ltd.
• Contact: Yingchang Mi, Doctor
• Phone: 86-10-22-23909999
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Vincristine Sulfate Liposome

• Vincristine Sulfate

Locations

Country	Name	City	State
China	Hospital of Blood Diseases, Chinese Academy of Medical Sciences	Tianjin

Sponsors (15)

Lead Sponsor

Collaborator

Nanjing Luye Sike Pharmaceutical Co.,Ltd.

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, Nanfang Hospital of Southern Medical University, Qilu Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Sichuan University of West China Hospital GCP Center, The First Affiliated Hospital of Zhengzhou University, The Second Hospital of Hebei Medical University, Xijing Hospital, Xinqiao Hospital of Chongqing, Xuzhou Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate(objectives (ORR)	ORR=CR+CRi CR(Complete response); No circulating blasts or extramedullary disease, No lymphadenopathy,splenomegaly,skin/gum infiltration/testicular mass/CNS involvement; Trilineage hematopoiesis(TLH)and <5% blast in bone marrow; ANC>1000/microl; Platelets>100,000/microl; CRi(Complete response with incomplete recovery of counts) Recovery of platelets but<100,000 or ANC is <1000/microl	up to 35 days	No
Primary	Incidence of General peripheral neuropathy	Chemotherapy-induced peripheral neuropathy was evaluated By Total Neuropathy Score clinical Version(TNSc).; If the score of any item of TNSc at anytime after the start of induction chemotherapy is higher than the baseline,it is considered that peripheral neuropathy occurs.	A week before enrollment. one,two,three and four weeks after the start of induction chemotherapy	Yes