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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
480
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Tianjin, China
RECRUITINGOverall response rate(objectives (ORR)
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
Time frame: up to 35 days
Incidence of General peripheral neuropathy
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.
Time frame: A week before enrollment. one,two,three and four weeks after the start of induction chemotherapy
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