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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: February 2017

Interventions

  • Drug: Vincristine Sulfate Liposome
  • Drug: Vincristine Sulfate

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Overall response rate(objectives (ORR)
    • Time Frame: 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
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nanjing Luye Sike Pharmaceutical Co., Ltd.
  • Collaborator
    • Ethics Committee of Blood Diseases Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Yingchang Mi, Doctor, 86-10-22-23909999

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