None listed
Conditions
Brief summary
The purpose of this study is to investigate the safety of low-dose lenalidomide treatment after allogeneic stem cell transplantation for patients with acute myeloid leukaemia or myelodysplastic syndromes at high risk of relapse. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with either high risk acute myeloid leukaemia (AML), OR high risk myelodysplastic syndrome (MDS). Study details All participants in this study will undergo treatment with the drug, lenalidomide, which will commence between day 40-45 after allogeneic stem cell transplant. Lenalidomide is an oral tablet, which will be taken for up to 48 weeks. The dose of lenalidomide in the study will commence at 2.5mg once per week, with subsequent groups increasing to 2.5mg twice per week, 5mg twice per week, 5mg every second day, 10mg every second day. Each participant will be assigned to receive one dose level for the entire study. The safety of lenalidomide treatment will be assessed by the incidence of side effects 120 days after starting the first dose of lenalidomide. This study will determine the safest dose of lenalidomide after allogeneic transplantation for patients at high risk of relapse.
Interventions
Phase I dose escalation study of micro-dose oral lenalidomide as maintenance therapy after allogeneic stem cell transplantation for patients with AML or MDS at high risk of relapse.
Participants commence lenalidomide oral tablets from day 40 post-allogeneic transplant, as per the dosing levels described below:
Dose level 1: lenalidomide 2.5mg oral weekly
Dose level 2: lenalidomide 2.5mg oral twice per week
Dose level 3: lenalidomide 5mg oral twice per week
Dose level 4: lenalidomide 5mg oral e
Phase I dose escalation study of micro-dose oral lenalidomide as maintenance therapy after allogeneic stem cell transplantation for patients with AML or MDS at high risk of relapse. Participants commence lenalidomide oral tablets from day 40 post-allogeneic transplant, as per the dosing levels described below: Dose level 1: lenalidomide 2.5mg oral weekly Dose level 2: lenalidomide 2.5mg oral twice per week Dose level 3: lenalidomide 5mg oral twice per week Dose level 4: lenalidomide 5mg oral every second day Dose level 5: lenalidomide 10mg oral every second day Treatment will continue for up to 48 weeks unless there is disease progression or unacceptable toxicity. Intervention adherence will not be routinely assessed.
Sponsors
Melbourne Health
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each patient must have one of the following: a. High risk AML, defined as any of: • Not in complete remission (CR) at time of alloHSCT • Adverse risk cytogenetics at any stage of disease • FLT3-ITD mutation • Prior induction failure • Evidence of pre-transplant minimal residual disease either by cytogenetics or by flow cytometry. If flow cytometry is the selected method used, MRD must be greater than 0.1%. • In second complete remission if duration of first complete remission was less than or equal to 6months. • Transformation from myeloid neoplasm at any stage OR b. High risk MDS, defined as any of: • Adverse risk cytogenetics at any stage of disease • Over 10% blasts in blood or marrow aspirate pre-transplant AND must meet ALL of the following general inclusion criteria: a. Age 18 years or older. b. No prior exposure to lenalidomide. c. Alkaline phosphatase and transaminases less than or equal to 2 x ULN d. Creatinine clearance greater than or equal to 30 ml/min (calculated by Cockcroft-Gault formula e. Females of childbearing potential must use an effective method of contraception or practice absolute abstinence for 4 weeks prior to lenalidomide therapy, during treatment and 4 weeks after treatment discontinuation f. Male patients must use contraception during lenalidomide treatment and for 1 week after completion of treatment g. ECOG performance status 0-2 h. Life expectancy greater than 6 months i. Patient’s written informed consent j. Subjects must agree not to share their medication and return unused supplies
Exclusion criteria
a. Grade 2-4 aGVHD b. Relapsed or progressive disease on screening bone marrow biopsy c. Active second malignancy currently requiring treatment d. Known hypersensitivity with anaphylactic reaction to lenalidomide e. Class III or IV cardiac disease defined by the NYHA. f. Severe or debilitating pulmonary disease. g. Severe or debilitating central nervous system disease or cerebral dysfunction. h. Active bacterial, viral or fungal infection i. Human Immuno-deficiency Virus (HIV) infection. j. Any coexisting medical or psychological condition that would preclude participation in the required study procedures. k. Female patients who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1
Outcome results
None listed