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Status unknownNCT02072785LY01609Updated Mar 3, 2014

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

A Phase 3 interventional study of Vincristine Sulfate Liposome and Vincristine Sulfate in Adult Acute Lymphoblastic Leukemia, sponsored by Nanjing Luye Sike Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-03-03.

Sponsored by Nanjing Luye Sike Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
480
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Adult Acute Lymphoblastic Leukemia

Keywords

  • Adult Acute Lymphoblastic Leukemia
  • Vincristine Sulfate Liposome
  • Vincristine Sulfate
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 480 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Nanjing Luye Sike Pharmaceutical Co., Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
480 participants (estimated)

Study arms

  • 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

Interventions

  • DrugVincristine Sulfate Liposome
  • DrugVincristine Sulfate
06

What researchers measure

Primary outcomes

  1. Overall response rate(objectives (ORR)

    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

    Time frame: up to 35 days

  2. 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.

    Time frame: A week before enrollment. one,two,three and four weeks after the start of induction chemotherapy

07

Study locations

1 of 1 sites recruiting
  • Hospital of Blood Diseases, Chinese Academy of Medical Sciences
    Tianjin, 300020, China
    • Yingchang MI, Doctor · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02072785
Lead 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
Responsible party
Sponsor
First posted
Feb 27, 2014
Start date
Jun 2013
Primary completion
Feb 2017 (estimated)
Completion
Feb 2017 (estimated)
Last update
Mar 3, 2014

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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