ALLG AML M16 : Sorafenib in combination with intensive chemotherapy for previously untreated adult FLT3-Internal Tandem Duplication (FLT3-ITD) - positive AML: A Phase II randomised placebo-controlled multi-centre study evaluating two year progression-free survival (Other ID's: U1111-1122-6056)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

15-65Age 15-65

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia

Trial Overview Read MoreRead more

This phase II trial is investigating the role of the drug sorafenib, given in combination with intensive chemotherapy for the treatment of Acute Myeloid Leukaemia (AML).
 

This trial is treating patients with Acute Myeloid Leukaemia.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.
  • You have a certain disease or psychological condition.

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

Sorafenib in combination with intensive chemotherapy for previously untreated adult FLT3-Internal Tandem Duplication (FLT3-ITD) - positive AML: A Phase II randomised placebo-controlled multi-centre study evaluating two year progression-free survival (Other ID's: U1111-1122-6056)

Cooperative Group

Australasian Leukaemia and Lymphoma Group (ALLG)

Summary

This study aims to determine the safety and efficacy of treatment with the drug Sorafenib, in combination with intensive chemotherapy for adults with previously untreated acute myeloid leukaemia (AML). Who is it for? You may be eligible to join this study if you are aged between 15-65 years and have been diagnosed with AML with FLT3-ITD mutation. You must have received no previous treatment for AML. Trial details All participants in this trial will undergo intensive chemotherapy over a period of minimum twelve months. Participants will be randomly (by chance) allocated to one of two groups. One group will receive the oral drug Sorafenib whilst undergoing chemotherapy and for a period of 12 months afterwards. The other group will receive a placebo (inactive) treatment in conjunction with chemotherapy. Participants will not know which group they are in until completion of the trial. Participants will be assessed at regular timepoints for a period of up to 5 years to determine the safety and clinical benefit of Sorafenib treatment in combination with chemotherapy. Treatment Duration will be a minimum of 1 year. This Phase II study will: Investigate the clinical benefit of frontline Sorafenib in combination with chemotherapy and during maintenance therapy in adult AML Optimise the dosing schedule of Sorafenib based on the kinetics of circulating FLT3 ligand levels after chemotherapy Investigate the clinical benefit of Sorafenib in relation to additional molecular AML lesions Identify pharmacokinetic and pharmacodynamic correlates of response predictive of treatment outcome.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Malignant Haematology & Stem Cell Transplantation Service
Prahran
Ms Janet Andrew
j.andrew@alfred.org.au
03 9076 5281

Box Hill Hospital, Malignant Haematology
Box Hill
Ms Lesley Poulton
lesley.poulton@monash.edu
03 9094 9502

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

Not Recruiting Hospitals Read MoreRead more

Closed

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

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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