LY01609: Phase III Study of Vincristine Sulfate Liposome For Injection In Adults With Naïve Acute Lymphoblastic Leukemia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vincristine Sulfate Liposome Vincristine 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. |
Drug: Vincristine Sulfate Liposome
|
| Active Comparator: Vincristine Sulfate Vincristine 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. |
Drug: Vincristine Sulfate
|
Outcome Measures
Primary Outcome Measures
- Overall response rate(objectives (ORR) [up to 35 days]
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
- Incidence of General peripheral neuropathy [A week before enrollment. one,two,three and four weeks after the start of induction chemotherapy]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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De novo untreated ALL patients diagnosed by the bone marrow morphology, immunophenotype.
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65 ≥ Age (years) ≥ 18 , male or female,
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ECOG Performance status of 0, 1, or 2.
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Patients must fulfill the following laboratory values
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Total bilirubin ≤2 ULN (corrected for same age)
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AST and ALT ≤3 ULN ( corrected for same ages)
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Serum creatinine ≤2 ULN (corrected for same age)
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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）.
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No neurological disorders, no nerve or muscle injury (motor and sensory nerve).
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Patient must sign the informed consent and obey the protocol.
Exclusion Criteria:
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Atopy or allergic to multiple medicines or excipients.
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With serious complications that affect compliance.
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Serious organ dysfunctions or central nervous system disorders.
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Mixed phenotype acute leukemia, (T-B).
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Burkitt lymphoma/leukemia.
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Suspected or confirmed central nervous system leukemia.
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Diabetes.
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Received antifungal treatment with triazole agents within 1 month before inclusion.
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Reliance of antipyretic and analgesic medicines or psychotropic medicines.
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Undergoing or has undergone other clinical trials in 4 weeks before inclusion.
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Pregnant women, women of breast feeding or childbearing potential without contraception.
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Psychological disorders that affect signing consent.
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The investigators believe that patients who are not suitable for inclusion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital of Blood Diseases, Chinese Academy of Medical Sciences | Tianjin | China | 300020 |
Sponsors and Collaborators
- Nanjing Luye Sike Pharmaceutical Co., Ltd.
- Ethics Committee of Blood Diseases Hospital
- Guangdong Provincial People's Hospital
- Qilu Hospital of Shandong University
- Xijing Hospital
- Xinqiao Hospital of Chongqing
- China Medical University, China
- West China Hospital
- Second Affiliated Hospital of Xi'an Jiaotong University
- The Second Hospital of Hebei Medical University
- The First Affiliated Hospital of Zhengzhou University
- Nanfang Hospital of Southern Medical University
- First Affiliated Hospital of Harbin Medical University
- Xuzhou Medical University
- First Affiliated Hospital of Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LUYESIKE-VSL-Ⅲ-01