AML Len 5
Trial overview
A 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
Inclusion criteria
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 protocol treatment and agree to participate in the Celgene approved process for Lenalidomide risk management and pregnancy prevention
7) Males must participate in the Celgene approved process for Lenalidomide risk management and pregnancy prevention
Exclusion criteria
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
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 Cooperative Oncology Group (ECOG) performance status >2
9) Myocardial dysfunction (as defined by left ventricular ejection fraction <50%)
10) Creatinine clearance <60 mls/min
11) ALT/AST >3 x ULN (Upper Limit of Normal)
Contact details
Other trials currently active for Myelodysplastic Syndromes
A randomised, double blind, placebo controlled study evaluating the efficacy and safety of romiplostim treatment of thrombocytopenia in subjects with international prognostic scoring system (IPSS) low or intermediate-1 risk Myelodysplastic Syndrome (MDS) as measured by the number of clinically significant bleeding events.
Molecular and functional characterisation of bone marrow function in normal subjects, myelodysplastic syndromes (MDS) and secondary disorders of haematopoiesis
The AML 17 trial has two distinct parts:
i.For patients with acute myeloid leukaemia (AML), (other than acute promyelocytic leukaemia) and High Risk Myelodysplasia, as defined by the WHO Classification (2001) (Appendix A, protocol).
ii.For adults with acute promyelocytic leukaemia (APL).
Tags
monotherapy lenalidomide mds acute myeloid leukaemia aml chemotherapy high risk myelodysplastic syndrome chromosome 5 len 5 ade