InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 7 February 2024

ALLG AML M16: 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)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)

Clinical summary

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.

Conditions

This trial is treating patients with Acute Myeloid Leukaemia.

Cancer

Blood Cancers Haematological

Age

People15 - 65

Phase

II

Trial Acronym

ALLG AML M16

More information

Trial Identifiers

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

Trial sponsor

Australasian Leukaemia and Lymphoma Group (ALLG)

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)

Eligibility

Inclusion

A morphological diagnosis of AML by WHO 2008 criteria, confirmed by special stains, immunophenotyping and, if available, cytogenetics. All clinico-pathological subtypes will be eligible, except for AML with t(15;17) or variants.

Patients with secondary and therapy related AML are eligible

FLT3-ITD mutation with an allelic mutant:wild-type ratio of = 0.05

Age 15 to 65 years inclusive.

ECOG performance status 0 to 2 inclusive

Absence of serious cardiac, pulmonary, hepatic or renal disease. A serum creatinine <1.5 times the upper limit of normal (ULN) and serum bilirubin < 2.5 times the upper limit of normal, is required for eligibility

Normal left ventricular ejection fraction, according to institutional criteria.

No previous treatment for AML or history of cancer (other than basal cell skin cancer or carcinoma of the cervix in situ, or other localised cancer treated by surgical excision only more than 5 years earlier without evidence of recurrence in the intervening period)

No contraindication to the use of the study drugs

Treatment must be given at an affiliated ALLG centre, with approval of the protocol by the institution’s Human Research Ethics Committee, or equivalent body

Written informed consent must be obtained from each patient prior to registration and start of treatment

Exclusion

Clinically active CNS leukaemia

Prior chemotherapy for AML (other than hydroxyurea ceased at least 24 hrs prior)

Known HIV positive

Known active hepatitis B or C, or any other active liver disease

Patients with parenchymal abnormality on screening chest x-ray must have no evidence of pulmonary infection on chest tomography (CT) prior to starting remission induction therapy

Any major surgery or radiation therapy within 4 weeks prior to study entry

Serious concomitant illnesses (for example, pulmonary infiltrate, unstable angina or myocardial infarction or stroke within 3 months prior to study entry, congestive heart failure AHA class 2 or greater, uncontrolled hypertension, uncontrolled diabetes, actively bleeding gastric ulcer, etc.), which in the investigator’s opinion would not make the patient a good candidate for the trial

Pregnant or breastfeeding

Any other known condition (e.g., familial, sociological, or geographical) or behaviour (including substance dependence or abuse, psychological or psychiatric illness), which in the investigator’s opinion would make the patient a poor candidate for the trial.

Inclusion

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

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

+ Show non-recruiting hospitals

Closed hospitals

Completed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

Submitting ... Please wait

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.