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

L

Luye Pharma Group

Status and phase

Unknown
Phase 3

Conditions

Adult Acute Lymphoblastic Leukemia

Treatments

Drug: Vincristine Sulfate Liposome
Drug: Vincristine Sulfate

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02072785
LUYESIKE-VSL-Ⅲ-01

Details and patient eligibility

About

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.

Enrollment

480 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

480 participants in 2 patient groups

Vincristine Sulfate Liposome
Experimental group
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.
Treatment:
Drug: Vincristine Sulfate Liposome
Vincristine Sulfate
Active Comparator group
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.
Treatment:
Drug: Vincristine Sulfate

Trial contacts and locations

0

Loading...

Central trial contact

Yingchang Mi, Doctor

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems