Phase III Study of Vincristine Sulfate Liposome For Injection In Adults With Naïve Acute Lymphoblastic Leukemia (LY01609)
Phase III Study of Vincristine Sulfate Liposome Or Vincristine Sulfate For Injection Combined Chemotherapy as Initial Induction Regimen In Adults Acute Lymphoblastic Leukemia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Tianjin, China, 300020
- Recruiting
- Hospital of Blood Diseases, Chinese Academy of Medical Sciences
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Contact:
- Yingchang MI, Doctor
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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)
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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. |
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall response rate(objectives (ORR)
Time Frame: up to 35 days
|
ORR=CR+CRi CR(Complete response)
CRi(Complete response with incomplete recovery of counts) Recovery of platelets but<100,000 or ANC is <1000/microl |
up to 35 days
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|
Incidence of General peripheral neuropathy
Time Frame: 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. |
A week before enrollment. one,two,three and four weeks after the start of induction chemotherapy
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Vincristine
Other Study ID Numbers
- LUYESIKE-VSL-Ⅲ-01
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