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Phase III Study of Vincristine Sulfate Liposome For Injection In Adults With Naïve Acute Lymphoblastic Leukemia (LY01609)

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ClinicalTrials.gov Identifier: NCT02072785
Recruitment Status : Unknown
Verified November 2013 by Nanjing Luye Sike Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : February 27, 2014
Last Update Posted : March 3, 2014
Sponsor:
Collaborators:
Ethics Committee of Blood Diseases Hospital
Guangdong General 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
Information provided by (Responsible Party):
Nanjing Luye Sike Pharmaceutical Co., Ltd.

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
Adult Acute Lymphoblastic Leukemia Drug: Vincristine Sulfate Liposome Drug: Vincristine Sulfate Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2013
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017


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



Primary Outcome Measures :
  1. Overall response rate(objectives (ORR) [ Time Frame: up to 35 days ]

    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


  2. 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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072785


Contacts
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Contact: Yingchang Mi, Doctor 86-10-22-23909999

Locations
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China
Hospital of Blood Diseases, Chinese Academy of Medical Sciences Recruiting
Tianjin, China, 300020
Contact: Yingchang MI, Doctor         
Sponsors and Collaborators
Nanjing Luye Sike Pharmaceutical Co., Ltd.
Ethics Committee of Blood Diseases Hospital
Guangdong General 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

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Responsible Party: Nanjing Luye Sike Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02072785     History of Changes
Other Study ID Numbers: LUYESIKE-VSL-Ⅲ-01
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: November 2013

Keywords provided by Nanjing Luye Sike Pharmaceutical Co., Ltd.:
Adult Acute Lymphoblastic Leukemia
Vincristine Sulfate Liposome
Vincristine Sulfate

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vincristine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action