This phase I trial is evaluating the safety and recommended dose of an oral therapy (Lenalidomide) in patients with Acute Myeloid Leukaemia or Myelodysplastic Syndrome at high risk of relapse.
This trial is treating patients with Acute Myeloid Leukaemia or Myelodysplastic Syndrome.
This is a systemic therapy trial.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
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Trial Identifiers
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Scientific Title
A Phase I study to assess the safety of micro-dose lenalidomide as maintenance therapy post-allogeneic haematopoietic cell transplantation for patients with acute myeloid leukaemia or myelodysplastic syndromes, at high risk of relapse
Commercial Sponsor
Celgene Corporation
Other Non-Commercial Sponsor
Royal Melbourne Hospital
Summary
This is a Phase I dose escalation study of micro-dose oral lenalidomide as maintenance therapy after allogeneic stem cell transplantation in patients with AML or MDS at high risk of relapse.
Participants commence oral lenalidomide treatment 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.
Not Recruiting Hospitals Read More