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

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.

Study Overview

• Status: Unknown
• Conditions: Adult Acute Lymphoblastic Leukemia
• Intervention / Treatment: Drug: Vincristine Sulfate; Drug: Vincristine Sulfate Liposome

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yingchang Mi, Doctor; Phone Number: 86-10-22-23909999

Study Locations

• China
  • Tianjin, China, 300020
    • Recruiting
    • Hospital of Blood Diseases, Chinese Academy of Medical Sciences
    • Contact: Yingchang MI, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

  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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate(objectives (ORR)	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	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

Collaborators and Investigators

• Sponsor: Nanjing Luye Sike Pharmaceutical Co., Ltd.
• Collaborators: China Medical University, China; Xijing Hospital; The Second Hospital of Hebei Medical University; West China Hospital; Qilu Hospital of Shandong University; Nanfang Hospital of Southern Medical University; First Affiliated Hospital of Zhejiang University; Xuzhou Medical University; The First Affiliated Hospital of Zhengzhou University; Guangdong Provincial People's Hospital; Xinqiao Hospital of Chongqing; Second Affiliated Hospital of Xi'an Jiaotong University; First Affiliated Hospital of Harbin Medical University; Ethics Committee of Blood Diseases Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ANTICIPATED): February 1, 2017
• Study Completion (ANTICIPATED): February 1, 2017

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (ESTIMATE): February 27, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 3, 2014
• Last Update Submitted That Met QC Criteria: February 27, 2014
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Vincristine Sulfate; Adult Acute Lymphoblastic Leukemia; Vincristine Sulfate Liposome
• 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