MicroLEN : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia,Leukaemia,Myelodysplasia

Trial Overview Read MoreRead more

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.

Clinical Summary Read MoreRead more

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.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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