Clinical trial NCT02072785: Phase III Study of Vincristine Sulfate Liposome For Injection In Adults With Naïve Acute Lymphoblastic Leukemia
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Adult Acute Lymphoblastic Leukemia
Keywords: Adult Acute Lymphoblastic Leukemia
Vincristine Sulfate Liposome
Vincristine Sulfate
Lead sponsor: Nanjing Luye Sike Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Ethics Committee of Blood Diseases Hospital
name: Guangdong Provincial People's Hospital
name: Qilu Hospital of Shandong University
name: Xijing Hospital
name: Xinqiao Hospital of Chongqing
name: China Medical University, China
name: West China Hospital
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: The Second Hospital of Hebei Medical University
name: The First Affiliated Hospital of Zhengzhou University
name: Nanfang Hospital, Southern Medical University
name: First Affiliated Hospital of Harbin Medical University
name: Xuzhou Medical University
name: First Affiliated Hospital of Zhejiang University
First posted: 2014-02-27
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

  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.

Primary outcomes:
measure: Overall response rate(objectives (ORR)
timeFrame: up to 35 days
measure: Incidence of General peripheral neuropathy
timeFrame: A week before enrollment. one,two,three and four weeks after the start of induction chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Study officials:
References: