A Randomised Phase III Study in Patients with Late Stage Acute Myeloid Leukaemia, comparing the efficacy, measured as overall survival (OS), of elacytarabine and investigator’s choice.

Clavis Pharma ASA0 个研究点目标入组 350 人开始时间: 2011年5月9日最近更新: 2020年1月13日

研究概览

暂无简介。

•Patients with a confirmed diagnosis of AML according to WHO classification
•(excluding acute promyelocytic leukaemia) who have received two or three
•previous induction/re-induction regimens. One of the (re-)induction regimens could
•be stem cell transplantation (SCT) for achievement of remission. Maintenance and
•consolidation (including SCT) may have been given, but are not counted as
•previous regimens.
•- Patient’s bone marrow aspirates and/or biopsies must contain > 5 % leukaemic
•blast cells or patient must have biopsy-proven extramedullary AML, or patient’s
•peripheral blood shows occurrence of leukaemic blast cells
•- Patients must
•a. have never attained CR or CRi (primary refractory), or
•b. have failed initial induction therapy, and have attained CR or CRi after
•salvage therapy(ies), and then relapsed within < 6 months, or
•c. have attained CR or CRi after initial induction therapy and relapsed within
•<12 months, and failed to respond to salvage therapy(ies), or
•d. have relapsed after the latest CR or CRi within < 6 months
•- Patients younger than 65 years should have received previous treatment with
•- Patients must have recovered from previous bone marrow and/or stem cell
•transplantation to a stage that the patient can tolerate the study treatment. There is
•no restriction on number of regimens or type of treatment administered for
•maintenance or consolidation during previous stages of the disease

•-Persistent clinically significant toxicities from previous chemotherapy
•-Impairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this
•clinical study
•- Active heart disease including myocardial infarction within previous 3 months,
•symptomatic coronary artery disease, arrhythmias not controlled by medication, or
•uncontrolled congestive heart failure. Any NYHA grade 3 or 4.
•- Patients receiving any anti-leukaemic agents within the last 4 weeks. Hydroxyurea, however, is allowed for up to 12 hours prior to study treatment.
•- Patients receiving any investigational treatment within the last 14 days

发起方