ACTRN12607000410459已完成2 期
A phase II trial in patients with acute promyelocytic leukaemia (APML) to evaluate the effects of: all-trans retinoic acid (ATRA) combined with intensive idarubicin during induction and consolidation; subsequent intermittent all-trans retinoic acid; and molecular monitoring for evidence of minimal residual leukaemia and for evidence of incipient relapse, as measured by remission rate, relapse rate and overall survival.
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 107 人开始时间: 2007年8月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
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
- 18 Years 至 -2147483648 No limit（—）
- 性别
- All
入选标准
- •1. Morphological diagnosis of de novo acute promyelocytic leukaemia
- •2. Demonstration of PML-RAR fusion transcripts by reverse transcriptase-polymerase chain reaction (RT-PCR)
- •3. Eastern Cooperative Oncology Group performance status 0-3, and absence of previous history of serious cardiac, pulmonary, hepatic or renal disease. A serum creatinine >200 micro mol/L or serum bilirubin
- •>80µmol/L precludes entry into the study, unless medically correctable.
- •4. A left ventricular ejection fraction of at least 50% as demonstrated by gated heart pool scan (preferably) or by cardiac ultrasound.
- •5. No previous treatment for APL, or history of cancer (other than basal cell skin cancer, or carcinoma of cervix in situ).
- •6. No contra-indication to use of any of the study drugs.
- •7. Treatment will be carried out at an affiliated ALLG centre, with approval of the protocol by the Institutional Human Ethics Committee or equivalent.
- •8. A negative pregnancy test in females of child-bearing age.
- •9. Written informed consent will be given by each patient.
排除标准
- •There are no specified exclusion criteria. All patients who met the inclusion criteria were eligible for the trial.
研究者
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