AMLM23 : A placebo controlled study to compare ivosidenib or enasidenib in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

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 III trial is investigating the safety and effectiveness of two types of targeted therapy in patients with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS).
 

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 had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A placebo controlled study to compare ivosidenib or enasidenib in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome

Other Non-Commercial Sponsor

Leukaemia Foundation

Summary

Eligible patients will receive up to two cycles of induction therapy, up to three cycles of consolidation therapy and maintenance treatment. Across the three treatments, patients will be randomly selected to receive a placebo (no treatment) or oral Enasidenib or Ivosidenaib once a day for the whole induction cycle, until the end of consolidation and for up to two years maintenance.

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

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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