title: [A prospective, multi-centre clinical trial to evaluate the early clinical efficacy and safety of a generic imatinib in treating patients with chronic phase of chronic myelogenous leukemia].
abstract: OBJECTIVE
  To evaluate the early hematologic, cytogenetic and molecular responses in newly diagnosed patients with chronic myelogenous leukemia in chronic phase（CML-CP）and initially treated with a generic imatinib（Xinwei）, manufactured by Jiansu Hansoh Pharmaceutical Group Co., Ltd.
  
  
  METHODS
  107 newly diagnosed patients of CML-CP, whose ages were above 18- year- old and who had never received any tyrosine kinase inhibitor（TKI）were treated with Xinwei 400 mg QD. The hematologic, cytogenetic and molecular responses were assessed at 3- and 6-month, and adverse effects were evaluated throughout the study.
  
  
  RESULTS
  107 patients were treated with Xinwei for at least 3 months, 54 of them were treated for 6 months or more. At 3- month, the complete hematologic responses（CHR）rate were 98.1%（105/107）; 47/57（82.5%） patients achieved major cytogenetic response（MCyR）, and 20/57 （35.1%） patients complete cytogenetic response（CCyR）; BCR- ABLIS was ≤10% in 77/106 patients （72.6%）, 11 of them（10.4%）achieved major molecular response（MMR, BCR-ABLIS was ≤0.1%）. At 6-month, the CHR rate was 100%（54/54）; 28/39 patients（71.8%）achieved CCyR; BCR-ABLIS was ≤1% in 37/54 patients （68.5% ）, 18 of them （33.3% ） achieved MMR. The grade Ⅲ leukopenia, thrombocytopenia and anemia rates were 19.5%, 23.0% and 13.8%, respectively. No grade Ⅳ hematologic toxicity occurred. The common non- hematologic toxicities were edema（74.7%）, nausea（48.3%）, bone pain（42.5%）, rash（36.8%）, diarrhea（34.5%）, fever（23.0%）, cramp（11.5%）and impaired liver function （3.4%）. No patient experienced grade Ⅳ non- hematologic toxicity. No adverse effects related death occurred.
  
  
  CONCLUSIONS
  Our results revealed the excellent early haematology, cytogenetic and molecular responses and safety of Xinwei in treating patients with CML-CP.
authors.forename: Qian
authors.initials: Q
authors.lastname: Jiang
authors.affiliation: Hematologic Disease and Tumor Institute of Harbin, Harbin 150010, China.
authors.forename: Donglu
authors.initials: D
authors.lastname: Zhao
authors.forename: Jie
authors.initials: J
authors.lastname: Jin
authors.forename: Depei
authors.initials: D
authors.lastname: Wu
authors.forename: Fanyi
authors.initials: F
authors.lastname: Meng
authors.forename: Jianda
authors.initials: J
authors.lastname: Hu
authors.forename: Bingcheng
authors.initials: B
authors.lastname: Liu
authors.forename: Xin
authors.initials: X
authors.lastname: DU
authors.forename: Ting
authors.initials: T
authors.lastname: Liu
authors.forename: Yan
authors.initials: Y
authors.lastname: Li
authors.forename: Ming
authors.initials: M
authors.lastname: Hou
authors.forename: Xiaopin
authors.initials: X
authors.lastname: Han
authors.affiliation: Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
authors.forename: Zhixiang
authors.initials: Z
authors.lastname: Shen
authors.affiliation: Hematologic Disease and Tumor Institute of Harbin, Harbin 150010, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Ma
mesh_terms: D000740:Anemia; D000971:Antineoplastic Combined Chemotherapy Protocols; D003582:Cytogenetics; D016568:Drugs, Generic; D006801:Humans; D000068877:Imatinib Mesylate; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors; D012074:Remission Induction; D013921:Thrombocytopenia; D016896:Treatment Outcome
chemical_list: D016568:Drugs, Generic; D047428:Protein Kinase Inhibitors; D000068877:Imatinib Mesylate