nil
ACTRN12610000627055
Treatment
Phase 1
Other Collaborative groups,Australasian Leukaemia and Lymphoma Group (ALLG)
Andrew Wei
Lenalidomide has a variety of reported mechanisms in blood malignancy, including activation of immune cells and anti-proliferative effects on tumor cells and modulation of the bone marrow microenvironment. Currently approved doses of lenalidomide use up to 25 mg for 21 days out of 28. A recent pilot study in older AML patients used higher and continuous doses of lenalidomide (50mg lenalidomide for 28 days x 2 cycles followed by 10 mg daily for 12 months). This resulted in a 30% complete response .... Read more
Subjects aged 15 - 65 years at screening. Newly diagnosed acute myeloid leukaemia (except APML) with morphology according to the World Health Organisation (WHO) criteria and confirmed by immunophenotyping. This can include de-novo and secondary/therapy related AML. The inclusion of patients with core binding factor AML and the presence of Fms-like tyrosine kinase 3 (FLT3) mutations will be allowable if patients are not enrolled for other studies targeting these disease groups. Has provided writt .... Read more
History of major non-compliance to medication. Evidence of known central nervous system (CNS) leukaemia. Currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that, in the nvestigator’s opinion, prevents the patient from absorbing or taking oral medication. Any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, .... Read more
No
Sample Size 45
Min. age 15 Years
Max. age 65 Years
Sex Both males and females
Condition category Newly diagnosed acute myeloid leukaemia (except Acute promyelocytic leukaemia (APML))
Condition code Cancer
Intervention code Treatment: Drugs
Daily oral lenalidomide maintenance therapy for consecutive 28 day cycles. The first two cycles will be 'high dose' lenalidomide (10-50mg depending on which of 5 cohorts is currently accruing patients), and then patients will complete up to 10 additional 28 day cycles of 10mg oral lenalidomide daily. Cohort 1: 10mg daily for first two cycles; then if approved by Trial Management Committee (TMC) Cohort 2: 25mg daily for first two cycles; then if approved by TMC Cohort 3: 30mg daily for first two .... Read more
Control group Uncontrolled
nil
Outcome: Determination of maximum tolerated dose (MTD) from dose limiting toxicities (DLTs) occurring in the first cycle of lenalidomide maintenance therapyTimepoint: Up to 28 days after the last evaluable patient from each cohort has completed 1 28 day cycles of 'high dose' lenalidomide therapy, the Trial management committee (TMC) will assess whether the next escalated dose cohort can commence accrual. The MTD will be the dose given to the cohort immediately preceding the .... Read more
Outcome: Adverse and serious adverse events during all cycles (up to 12 months) of Lenalidomide maintenance therapy as assessed by Common terminology criteria for Avderse Events (CTCAE) version 4 criteriaTimepoint: 12 months after final patient was accrued to the study.
yes
De-identified IPD data, for all data collected during the trial
Data available 3 months following publication, for an indefinite period
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Any type of analysis Assessed on a case-by-case basis