Pilot safety/tolerability study of Lenalidomide administered as monotherapy and in combination with standard chemotherapy for Acute Myeloid Leukaemia/high-risk myelodysplastic syndrome with structural abnormalities of chromosome 5 - AML Len5

eeds Teaching Hospitals Trust0 个研究点目标入组 14 人开始时间: 2009年5月21日最近更新: 2019年11月25日

试验速览

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•1) Patients diagnosed with primary/relapsed/refractory AML (as defined by WHO) or high risk MDS (defined as IPSS INT-2/High) with chromosome 5 cytogenetic abnormalities.
•2) Aged at least 18 years old
•3) Considered suitable for intensive chemotherapy
•4) The subject is capable of understanding and complying with protocol requirements.
•5) The subject signs a written, informed consent form prior to the initiation of any study procedures
•6) Females of child bearing potential must have a negative pregnancy test within 14 days prior to start of lenalidomide and agree to participate and follow the Celgene approved process for Lenalidomide risk management and pregnancy prevention.
•7) Males must participate and follow the Celgene approved process for Lenalidomide risk management and pregnancy prevention.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•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) Use of prior investigational agents within 4 weeks prior to consent
•2) The subject has received lenalidomide in a previous clinical study or as a therapeutic agent.
•3) The subject has a history or clinical manifestations of HIV, Hepatitis B or Hepatitis C.
•4) The subject has a history of hypersensitivity or allergies to lactose.
•5) If female, the subject is pregnant or lactating.
•6) The subject has another active malignancy
•7) The subject has other severe concurrent disease or mental illness
•8) Eastern Cooperateive Oncology Group (ECOG) performance status greater than 2 (Appendix 2).
•9) Myocardial dysfunction (as defined by left ventricular ejection fraction <50%)
•10) Creatinine clearance (Cockroft) <60 mls/min
•11) ALT/AST >3 xULN

发起方

eeds Teaching Hospitals Trust