Phase III Study of Vincristine Sulfate Liposome For Injection In Adults With Naïve Acute Lymphoblastic Leukemia
LY01609
1 other identifier
interventional
480
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2013
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 25, 2014
CompletedFirst Posted
Study publicly available on registry
February 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMarch 3, 2014
November 1, 2013
3.7 years
February 25, 2014
February 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall response rate(objectives (ORR)
ORR=CR+CRi CR(Complete response) 1. No circulating blasts or extramedullary disease, No lymphadenopathy,splenomegaly,skin/gum infiltration/testicular mass/CNS involvement 2. Trilineage hematopoiesis(TLH)and \<5% blast in bone marrow 3. ANC\>1000/microl 4. 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
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
Study Arms (2)
Vincristine Sulfate Liposome
EXPERIMENTALVincristine Sulfate For Injection simulation agent 1.4mg/m2,(2mg, maximum dose), iv, d1, d8, d15, d22. Vincristine Sulfate Liposome For Injection: 1.4mg/m2, (2mg, maximum dose), iv, d1, d8, d15, d22. Duration between these two agents should be more than 2.5h, and saline should be avoided for flushing before Vincristine Sulfate Liposome For Injection.
Vincristine Sulfate
ACTIVE COMPARATORVincristine Sulfate For Injection 1.4mg/m2,(2mg, maximum dose), iv, d1, d8, d15, d22. Vincristine Sulfate Liposome For Injection simulation agent: 1.4mg/m2,(2mg, maximum dose), iv, d1, 8, 15, 22. Duration between these two agents should be more than 2.5h, and saline should not be used for flushing before Vincristine Sulfate Liposome For Injection simulation agent.
Interventions
Eligibility Criteria
You may qualify if:
- De novo untreated ALL patients diagnosed by the bone marrow morphology, immunophenotype.
- ≥ Age (years) ≥ 18 , male or female,
- ECOG Performance status of 0, 1, or 2.
- Patients must fulfill the following laboratory values
- Total bilirubin ≤2 ULN (corrected for same age)
- AST and ALT ≤3 ULN ( corrected for same ages)
- Serum creatinine ≤2 ULN (corrected for same age)
- No neurological disorders, no nerve or muscle injury (motor and sensory nerve).
- Patient must sign the informed consent and obey the protocol.
You may not qualify if:
- 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.
- Reliance of antipyretic and analgesic medicines or psychotropic medicines.
- Pregnant women, women of breast feeding or childbearing potential without contraception.
- Psychological disorders that affect signing consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanjing Luye Sike Pharmaceutical Co., Ltd.lead
- Ethics Committee of Blood Diseases Hospitalcollaborator
- Guangdong Provincial People's Hospitalcollaborator
- Qilu Hospital of Shandong Universitycollaborator
- Xijing Hospitalcollaborator
- Xinqiao Hospital of Chongqingcollaborator
- China Medical University, Chinacollaborator
- West China Hospitalcollaborator
- Second Affiliated Hospital of Xi'an Jiaotong Universitycollaborator
- The Second Hospital of Hebei Medical Universitycollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
- First Affiliated Hospital of Harbin Medical Universitycollaborator
- Xuzhou Medical Universitycollaborator
- First Affiliated Hospital of Zhejiang Universitycollaborator
Study Sites (1)
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Tianjin, 300020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2014
First Posted
February 27, 2014
Study Start
June 1, 2013
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
March 3, 2014
Record last verified: 2013-11