A Phase II Trial of Clofarabine in Older Patients with Acute Myeloid Leukaemia for Whom Intensive Chemotherapy is Not Considered Suitable

Bioenvision Limited0 个研究点开始时间: 2005年7月20日最近更新: 2012年12月17日

适应症

试验速览

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•1. Patients must have untreated AML as defined by the WHO classification 2. Patients must provide written informed consent. 3. Male or Post-Menopausal female patients ≥ 65 years of age and unsuitable for intensive chemotherapy. 4. Male patients who are fertile agree to use an effective barrier method of birth control to avoid pregnancy. 5. Patients must be able to comply with study procedures and follow-up examinations. 6. Patients must have adequate organ function as indicated by the following laboratory values, obtained within 7 days prior to enrolment. Serum Bilirubin < 1.5 x ULN AST and ALT < 2 x ULN Creatinine < 1.5 x ULN Prothrombin Time < 1.5 x control ULN = Institutional Upper Limit of Normal.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Patients who have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment. 2. Patients who have a psychiatric disorder(s) that would interfere with consent, study participation or follow-up. 3. Patients who are receiving other chemotherapy or corticosteroids (unless the latter is administered at a low dose for pre-medication purposes or for the treatment of chronic conditions - e.g., rheumatoid arthritis). 4. Patients who have received prior treatment for leukaemia. Patients who have received growth factor, cytokine support, leukopheresis or, hydroxyurea, will be allowed into the study but must discontinue treatment at least 24 hours prior to beginning treatment with clofarabine. 5. Patients who have any other severe concurrent disease (severe Coronary Artery Disease (CAD), significant neurological disorder, uncontrolled diabetes, etc), which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 6. Patients who have symptomatic Central Nervous System (CNS) involvement. 7. Patients who have previously received clofarabine. 8. Patients who are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days. 9. Blast transformation of chronic myeloid leukaemia or acute promyelocytic leukaemia.

发起方

Bioenvision Limited