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

Primary Purpose

Adult Acute Lymphoblastic Leukemia

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Vincristine Sulfate Liposome
Vincristine Sulfate
Sponsored by
Nanjing Luye Sike Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Lymphoblastic Leukemia focused on measuring Adult Acute Lymphoblastic Leukemia, Vincristine Sulfate Liposome, Vincristine Sulfate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital of Blood Diseases, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vincristine Sulfate Liposome

Vincristine Sulfate

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2014
Last Updated
February 27, 2014
Sponsor
Nanjing Luye Sike Pharmaceutical Co., Ltd.
Collaborators
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, Southern Medical University, First Affiliated Hospital of Harbin Medical University, Xuzhou Medical University, First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT02072785
Brief Title
Phase III Study of Vincristine Sulfate Liposome For Injection In Adults With Naïve Acute Lymphoblastic Leukemia
Acronym
LY01609
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing Luye Sike Pharmaceutical Co., Ltd.
Collaborators
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, Southern Medical University, First Affiliated Hospital of Harbin Medical University, Xuzhou Medical University, First Affiliated Hospital of Zhejiang University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Acute Lymphoblastic Leukemia
Keywords
Adult Acute Lymphoblastic Leukemia, Vincristine Sulfate Liposome, Vincristine Sulfate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vincristine Sulfate Liposome
Arm Type
Experimental
Arm Description
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.
Arm Title
Vincristine Sulfate
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vincristine Sulfate Liposome
Intervention Type
Drug
Intervention Name(s)
Vincristine Sulfate
Primary Outcome Measure Information:
Title
Overall response rate(objectives (ORR)
Description
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
Time Frame
up to 35 days
Title
Incidence of General peripheral neuropathy
Description
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.
Time Frame
A week before enrollment. one,two,three and four weeks after the start of induction chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingchang Mi, Doctor
Phone
86-10-22-23909999
Facility Information:
Facility Name
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
City
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingchang MI, Doctor

12. IPD Sharing Statement

Learn more about this trial

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

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