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

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

  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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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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