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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Adult Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Vincristine Sulfate Liposome

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Vincristine Sulfate

Intervention Type DRUG

Interventions

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Vincristine Sulfate Liposome

Intervention Type DRUG

Vincristine Sulfate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No