Adult Acute Lymphoblastic Leukemia
Conditions
Keywords
Adult Acute Lymphoblastic Leukemia, Vincristine Sulfate Liposome, Vincristine Sulfate
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.
Interventions
DRUGVincristine Sulfate
Sponsors
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
Nanjing Luye Sike Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate(objectives (ORR) | up to 35 days | 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 |
| Incidence of General peripheral neuropathy | A week before enrollment. one,two,three and four weeks after the start of induction chemotherapy | 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. |
Countries
China
Contacts
Primary ContactYingchang Mi, Doctor
Outcome results
None listed