ACTRN12612000847819撤回2 期
A Phase II study of failure-free survival following treatment with midostaurin in combination with standard chemotherapy in newly diagnosed patients with Core Binding Factor Acute Myeloid Leukaemia
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 50 人开始时间: 2012年8月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 15 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.Newly diagnosed patients with a morphologically confirmed diagnosis of AML with t(8;21); RUNX1-RUNX1T1 or AML with inv(16) or t(16;16); CBFB-MYH11 by World Health Organisation criteria which includes patients with <20% blasts in the presence of cytogenetic or molecular evidence of a CBF subtype
- •2.Confirmation of CBF subtype by cytogenetic finding (including Fluorescence in situ hybridization (FISH)) of t(8;21)(q22;q22) or inv(16)(p13;q22) or t(16;16)(p13;q22) (either alone or in combination with other cytogenetic abnormalities) OR polymerase chain reaction (PCR) evidence of a CBF fusion transcript (RUNX1-RUNX1T1 or CBF-MYH11).
- •3.Age between 15 and 65 inclusive
- •4.Life expectancy at least 3 months
- •5.Females of childbearing potential use a highly effective method of contraception and a form of barrier contraception for the duration of the study and for 3 months after midostaurin treatment is ceased
- •6.Adequate renal and hepatic functions to enable safe delivery of chemotherapy.
- •a.Total bilirubin <1.5 x Upper Limit of Normal (ULN)
- •b.aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <2.5 ULN
- •c.serum creatinine <250micromol/L
- •Patients not meeting these criteria should be discussed with Principal Investigator
- •7.An Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
- •8.Patients must be registered prior to the commencement of induction therapy. Where there is a need for urgent commencement of induction therapy, patients with subsequent confirmation of the CBF subtype following commencement of induction therapy may be considered, after discussion with a study Principal Investigator, for inclusion in this trial. The continuation, or modification, of the induction phases of their treatment will be determined by the investigator in consultation with a Principal Investigator, but post-remission consolidation therapy will follow the treatment plan for this study (AMLM19).
- •9.Has provided written informed consent
排除标准
- •1.Prior therapy for AML (Hydroxyurea allowed up to 5 days and circumstances in Inclusion criterion 8 will be considered)
- •2.Patients with central nervous sytem (CNS) involvement with AML
- •3.Serious cardiac or pulmonary dysfunction precluding the delivery of the proposed therapy
- •4.Women who are pregnant or lactating. Women of child-bearing potential must have a negative serum pregnancy test at Screening.
- •5.Prior diagnosis of cancer that was:
- •a.more than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10%
- •b.within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
- •6.Contraindication to the use of study drugs
- •7.Severe active infection
- •8.Known human immunodeficiency virus (HIV) or Hepatitis C Virus (HCV) infection or Hepatitis V virus surface antigen (HBV-sAg) positivity
- •9.Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study
- •10.Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
研究者
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