ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001334392p

Ethics application status

Not yet submitted

Date submitted

8/10/2026

Date registered

5/11/2026

Date last updated

5/11/2026

Date data sharing statement initially provided

5/11/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

ALLG AMLM28/A4 (ADAPT): Achieving Durable remissions via Adaptive Pro-survival Targeting in acute myeloid leukaemia (AML)) – VEN/AZA/Lasmotinib. A therapeutic arm of the ALLG AMLM28 ADAPT Study-Master Protocol.

Scientific title

Additional trial identifiers [1]

AMLM28/A4

Additional trial identifiers [2]

APA A4-ADAPT

Universal Trial Number (UTN)

Trial acronym

Related trial records

A sub-study of the ADAPT Study Master protocol ACTRN12623000900617

Health condition

Health condition(s) studied:

Acute Myeloid Leukaemia

Condition category

Condition code

Cancer

Leukaemia - Acute leukaemia

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

The intervention is Lasmotinib. Lasmotinib is supplied as a tablet (20mg) to be administered once daily with 240mL of water, with a minimum fasting requirement at least 2 hours before and after administration.

The patients enrolled into this therapeutic arm is part of the following domains from the ALLG AMLM28 ADAPT master protocol (ID ACTRN12623000900617) will have a confirmed FLT3-ITD mutant AML by capillary electrophoresis and a NPM1 mutation status at AML diagnosis.

Safety run-in phase. 12 patients to be enrolled.
Lasmotinib will be co-administered with standard of care treatment consisting of Venetoclax and Azacitidine on a 28 day cycle for 12 cycles:
-Azacitidine (75mg/m^2 per day) will be administered subcutaneous (SC) or intravenous (IV) from day 1 to day 9 for a total of 7 doses. From cycle 2 onwards, patients are permitted to have two days off between day 1-9.
-Venetoclax (400mg) will be administered orally once a day from day 1 to day 21. There will be a 3 day ramp up from 100mg, 200mg, and 400mg on day 1, day 2, and day 3, respectively.
-Lasmotinib will be administered orally once a day from day 8-day 28 starting at 160 mg.

The first dose level explored will be Level 160mg, with tolerability assessed at the end of the first cycle of study therapy, based on the occurrence of dose limiting toxicities (DLTs). In addition to dose reduction, the duration and schedule of Lasmotinib administration may be modified based on safety run-in data. The recommended Phase II dose (RP2D) may incorporate changes to both the daily dose and dosing schedule, based on observed DLTs, safety, tolerability and emerging efficacy data reviewed by the Trial Management Committee.

Dose Expansion Phase. Additional 30 patients will be enrolled.
The dose-expansion phase will commence once all required Cycle 1 safety data from the safety run-in phase have been reviewed, the RP2D has been determined, and approval to proceed has been provided by the Trial Management Committee. Once the recommended dose is determined from the safety run-in, Lasmotinib will continue to be administered with venetoclax and azacitidine on the same 28-day cycle for a total of 12 cycles:

Azacitidine: 75 mg/m² IV daily on Days 1–5
Venetoclax: 400 mg orally once daily on Days 1–21
Lasmotinib: Dose and schedule as determined from safety run-in and approved by the Trial Management Committee. The final regimen may differ from the initial schedule evaluated in the safety run-in and may include modifications to both dose level and duration of administration based on the safety run-in findings.

All treatment will be administered by the study team. Drug accountability will be performed by the administering institutions to assess compliance. Drug accountability is assessed through a combination of medical records, dispensing documentation, and physical review of returned medication packaging.

Intervention code [1]

Treatment: Drugs

Description of the comparator or control

The comparator is standard-of-care treatment consisting of venetoclax and azacitidine.

The patients enrolled into this therapeutic arm as part of the following domains from the ALLG AMLM28 ADAPT master protocol (ID ACTRN12623000900617) will have a confirmed FLT3-ITD mutant AML by capillary electrophoresis and a NPM1 mutation status at AML diagnosis.

Standard-of-Care Arm. Additional 30 patients will be enrolled.

Venetoclax and azacitidine will be administered on a 28-day cycle for a total of 12 cycles:

Azacitidine (75mg/m² per day) will be administered subcutaneously (SC) or intravenously (IV) from Day 1 to Day 9 for a total of 7 doses. From Cycle 2 onwards, patients are permitted to have two days off between Day 1 and Day 9.
Venetoclax (400mg) will be administered orally once daily from Day 1 to Day 21. There will be a 3-day ramp-up from 100mg, 200mg and 400mg on Day 1, Day 2 and Day 3, respectively.

Treatment will continue on the same 28-day cycle schedule for up to 12 cycles, or until disease progression, unacceptable toxicity, withdrawal of consent, commencement of alternative anti-leukaemic therapy, or study discontinuation, whichever occurs first.

All treatment will be administered by the study team. Drug accountability will be performed by the administering institutions to assess compliance. Drug accountability is assessed through a combination of medical records, dispensing documentation, and physical review of returned medication packaging.

Control group

Active

Outcomes

Primary outcome [1]

Establish a recommended phase 2 dose (RP2D) of Lasmotinib for the triplet therapy during the safety run-in phase only.

Timepoint [1]

Date of randomisation to day 28 of the treatment cycle (safety run-in phase participants only).

Primary outcome [2]

Achievement of either complete remission (CR), complete remission with incomplete haematologic recovery (CRi), or complete remission with partial haematologic recovery (CRh) as a composite outcome. This will be defined as the proportion of participants achieving CR, CRi, or CRh.

Timepoint [2]

Baseline, day 21 of cycle 1 of treatment, day 28 of cycle 2-12 of treatment, at the end of treatment, 3 monthly follows ups until 12 months from the end of treatment. Primary timepoint is whether patients achieve undetectable MRD within 180 days of commencing treatment.

Secondary outcome [1]

Overall survival

Timepoint [1]

Date of randomisation to the date of death from any cause. Up to 12 months after treatment has stopped.

Secondary outcome [2]

Event Free Survival

Timepoint [2]

Baseline, day 21 of cycle 1 of treatment, day 28 of cycle 2-12 of treatment, at the end of treatment, 3 monthly follows ups until 12 months from the end of treatment. Measured from the start of treatment commencement to the date of treatment failure (not reaching CR/CRh/CRi by 180 days from treatment commencement), hematologic relapse, or death from any cause, whichever occurs first.

Secondary outcome [3]

Relapse Free Survival (RFS)

Timepoint [3]

Measured from the start of treatment commencement to the date of treatment failure, hematologic relapse, or death from any cause, whichever occurs first. Up to 12 months after end of treatment.

Secondary outcome [4]

Safety

Timepoint [4]

Time from randomisation, continuous during treatment, and up to 12 months after treatment has stopped.

Secondary outcome [5]

Tolerability

Timepoint [5]

Time from randomisation, continuous during treatment, and up to 12 months after treatment has stopped.

Secondary outcome [6]

Duration of FLT3-ITD MRD negative Remission

Timepoint [6]

Baseline, day 21 of cycle 1 of treatment, day 28 of cycle 2-12 of treatment, at the end of treatment, 3 monthly follows ups until 12 months from the end of treatment.

Secondary outcome [7]

Quality of life

Timepoint [7]

At randomisation, day 1 of cycle 2, day 1 of cycle 4, day 1 of cycle 6, day 1 of cycle 8, and day 1 of cycle 12.

Secondary outcome [8]

Quality of life

Timepoint [8]

At start of treatment, day 1 of cycle 2, day 1 of cycle 4, day 1 of cycle 6, day 1 of cycle 8, and day 1 of cycle 12.

Secondary outcome [9]

Event Free Survival

Timepoint [9]

Measured from the start of treatment commencement to the date of treatment failure (not reaching CR/CRh/CRi by 180 days from treatment commencement), hematologic relapse, death from any cause, or treatment with allogeneic stem cell transplantation (ASCT), whichever occurs first. Up to 12 months after end of treatment.

Secondary outcome [10]

Relapse Free Survival (RFS)

Timepoint [10]

Measured from the start of treatment commencement to the date of treatment failure, hematologic relapse, death from any cause, or treatment with ASCT, whichever occurs first. Up to 12 months after end of treatment.

Secondary outcome [11]

Deliverability

Timepoint [11]

At start of treatment until the end of 12 cycles of treatment.

Eligibility

Key inclusion criteria

1. Patients or their legally authorised representative must voluntarily sign and date an informed consent form approved by a Human Research Ethics Committee (HREC) prior to the initiation of any screening or trial-specific procedures.
2. Meets the inclusion and exclusion criteria in the AMLM28 ADAPT Master Protocol ACTRN ACTRN12623000900617.
3. Aged 18 years and older.
4. Confirmed fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) mutant acute myeloid leukaemia by capillary electrophoresis.
5. Nucleophosmin 1 (NPM1) mutation status at acute myeloid leukaemia diagnosis is known (required for stratification in the randomised phase only).
6. Eligible for Pharmaceutical Benefit Scheme (PBS) reimbursed standard-of-care azacitidine and venetoclax (AZA-VEN) therapy.
7. Patient has received no prior therapy for acute myeloid leukaemia except for hydroxyurea, which may be used to control the white blood cell count in cycle 1. A single dose of intravenous (IV) or subcutaneous (SC) cytarabine up to a dose of 500 milligrams for cytoreduction is permitted.
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
9. Patient must have adequate liver function, defined as:
a. Aspartate aminotransferase (AST) less than 3 times the upper limit of normal (ULN); and
b. Alanine aminotransferase (ALT) less than 3x ULN; and
c. Bilirubin less than or equal to 1.5X ULN.
Exception: elevated bilirubin is permitted if considered related to acute myeloid leukaemia or Gilbert syndrome.
10. Patient must have adequate renal function as demonstrated by a creatinine clearance of at least 30 millilitres per minute, calculated using the Cockcroft-Gault formula.
11. Patients of childbearing potential must have a negative serum pregnancy test 10 to 14 days prior to registration and within 24 hours prior to commencing trial treatment. The pregnancy test must be sensitive to at least 25 milli-international units per millilitre.
12. Patient agrees to follow the recommended contraception procedures for this treatment domain, as outlined below.
Female patients must be either:
a. Postmenopausal, defined as:
i. Age greater than 55 years with no menses for 12 or more months without an alternative medical cause; or
ii. Age 55 years or younger with no menses for 12 or more months without an alternative medical cause and a follicle-stimulating hormone (FSH) level greater than 40 international units per litre.
OR
b. Permanently surgically sterile through bilateral oophorectomy, bilateral salpingectomy, or hysterectomy.
OR
c. A woman of childbearing potential (WOCBP) practising at least one protocol-specified method of contraception starting on Day 1 through at least 180 days after the last dose of study drug, , to practice the protocol specified Contraception outlined below. Male patients must agree to refrain from sperm donation from initial study drug administration through at least 90 days after the last dose of study drug.

Male patients who are sexually active, must agree, from day 1 through at least 180 days after the last dose of study drug, to practice the protocol specified Contraception outlined below. Male patients must agree to refrain from sperm donation from initial study drug administration through at least 90 days after the last dose of study drug.

Females of childbearing potential must have negative pregnancy test results performed:
a. At screening, using a serum sample obtained within 7 days prior to the first study drug administration; and
b. For patients with borderline pregnancy test results at screening, a repeat serum pregnancy test at least 3 days later documenting the absence of a positive result.
While participating in this research study, female patients must not become pregnant or breastfeed. Male patients must not father a child.
Unless postmenopausal or permanently surgically sterile, a woman of childbearing potential must practise at least one of the following methods of contraception from Study Day 1, or earlier, through at least 180 days after the last dose of study drug:
a. Combined hormonal contraception containing oestrogen and progestogen (oral, intravaginal, or transdermal), associated with inhibition of ovulation and initiated at least 1 month prior to Study Day 1. Participants must also use a barrier method during the study from initial study drug administration until 180 days after the last dose of study drug.
b. Progestogen-only hormonal contraception (oral, injectable, or implantable), associated with inhibition of ovulation and initiated at least 1 month prior to Study Day 1. Participants must also use a barrier method during the study from initial study drug administration until 180 days after the last dose of study drug.
c. Bilateral tubal occlusion or ligation, or bilateral tubal occlusion via hysteroscopy, provided a hysterosalpingogram confirms successful completion of the procedure.
d. A vasectomised partner, provided the vasectomised partner verbally confirms medical assessment of surgical success, the vasectomy occurred more than 3 months prior to screening, and the partner is the sole sexual partner of the trial participant.
e. An intrauterine device (IUD).
f. An intrauterine hormone-releasing system (IUS).
g. True abstinence, defined as refraining from heterosexual intercourse when this is in line with the participant's preferred and usual lifestyle. Periodic abstinence methods, including calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal, are not acceptable.
Male patients who are sexually active with a woman of childbearing potential, even if the male patient has undergone a successful vasectomy, must agree:
a. From Study Day 1 through at least 180 days after the last dose of study drug, to use condoms, and their female partner must use at least one protocol-specified contraceptive method for female patients of childbearing potential.
b. Not to donate sperm from Study Day 1 through at least 180 days after the last dose of study drug.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

Presence of any of the following criteria will exclude the patient from enrolment in the trial.
1. Presence of any general exclusion criteria outlined in the AMLM28 ADAPT Master Protocol. ACTRN12623000900617
2. Core binding factor acute myeloid leukaemia (AML).
3. Antecedent chronic myeloid leukaemia (CML) or CML in blast phase.
4. Antecedent myelofibrosis (including primary and secondary).
5. A history of severe allergic or anaphylactic reactions to any component or excipient of lasmotinib.
6. Malabsorption syndrome or another condition that precludes enteral administration.
7. Clinically significant cardiovascular disease, such as:
a. Screening 12-lead electrocardiogram (ECG) showing a baseline QT interval corrected using Fridericia's formula (QTcF) greater than 470 milliseconds.
b. Significant cardiovascular disability corresponding to New York Heart Association (NYHA) Class III or IV.
c. History of congestive heart failure classified as New York Heart Association Class III or IV, unless a screening echocardiogram or gated cardiac blood pool scan performed within 1 month prior to study entry demonstrates a left ventricular ejection fraction (LVEF) of 45 per cent or greater.
8. Clinically significant chronic respiratory disease requiring continuous oxygen therapy.
9. History of, or current, drug-induced interstitial lung disease or pneumonitis.
10. White blood cell count greater than 15 × 10^9 per litre. Hydroxyurea may be used to control the white blood cell count during cycle 1. A single dose of intravenous (IV) or subcutaneous (SC) cytarabine up to 500 milligrams for cytoreduction is permitted.
11. Active bleeding or clinically relevant prolongation of activated partial thromboplastin time (APTT) or international normalized ratio (INR), defined as INR greater than 2.0X ULN; or
APTT greater than 2.0x ULN, not attributable to therapeutic anticoagulation.
12. Underlying medical conditions that, in the investigator's opinion, would render administration of the trial drug hazardous or obscure the interpretation of safety or efficacy results.
13. Positive serology for human immunodeficiency virus (HIV).
14. Evidence of clinically significant uncontrolled infection, including but not limited to:
a. Clinically significant active systemic infection, whether viral, bacterial, or fungal, requiring therapy.
b. Active hepatitis B infection, defined as detectable hepatitis B virus deoxyribonucleic acid (HBV DNA) or positive hepatitis B surface antigen (HBsAg). Patients who are positive for hepatitis B core antibody (HBcAb) but negative for hepatitis B virus deoxyribonucleic acid and hepatitis B surface antigen are eligible. These patients will undergo monthly hepatitis B virus deoxyribonucleic acid monitoring throughout the trial and receive appropriate antiviral prophylaxis, such as entecavir, according to infectious diseases specialist advice. Patients who have received intravenous immunoglobulin (IVIG) may have false-positive hepatitis B core antibody results. In these patients, if hepatitis B virus deoxyribonucleic acid and hepatitis B surface antigen are negative, antiviral prophylaxis may be omitted if considered unnecessary by the infectious diseases service; however, monitoring of hepatitis B virus deoxyribonucleic acid levels remains required.
c. Active hepatitis C infection, defined by detection of hepatitis C virus ribonucleic acid (HCV RNA) in plasma by polymerase chain reaction (PCR). Patients who have received treatment intended to eradicate hepatitis C virus may participate if hepatitis C virus ribonucleic acid remains undetectable.
15. Receipt of a live attenuated vaccine within 28 days prior to initiation of trial treatment. Examples include, but are not limited to:
a. Measles vaccine.
b. Mumps vaccine.
c. Rubella vaccine.
d. Varicella-zoster (chickenpox) vaccine.
e. Yellow fever vaccine.
f. Rabies vaccine.
g. Bacillus Calmette-Guérin (BCG) vaccine.
h. Typhoid vaccine.
Seasonal injectable influenza vaccines are generally inactivated vaccines and are permitted. Intranasal influenza vaccines, such as FluMist, are live attenuated vaccines and are not permitted. Experimental and/or non-authorised severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are not permitted.
16. History of another malignancy, except:
a. A malignancy treated with curative intent, with no known active disease for at least 2 years before the first dose of trial drug, and considered by the treating physician to be at low risk of recurrence.
b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
c. Adequately treated carcinoma in situ without evidence of disease.
d. Localised prostate cancer following radical prostatectomy, or prostate cancer with stable, non-rising prostate-specific antigen (PSA) levels less than 0.1 nanograms per millilitre.
17. Current autoimmune disease requiring immunosuppressive therapy other than prednisolone at a dose less than or equal to 20 milligrams daily, or equivalent.
18. Administration or consumption of any of the following within 3 days prior to the first dose of venetoclax:
a. Grapefruit or grapefruit products.
b. Seville oranges, including marmalade containing Seville oranges.
c. Star fruit.
19. Patient is unable to undergo a 5-day washout period prior to commencing the first dose of study drug for:
a. Strong or moderate cytochrome P450 3A (CYP3A) inducers, such as rifampin, carbamazepine, phenytoin, and St John's wort.
20. History of clinically significant medical conditions, or any other reason that the investigator determines would interfere with the patient's participation in this trial or make the patient an unsuitable candidate to receive the trial drug.
21. Female patient who is pregnant, breastfeeding, considering becoming pregnant, or planning to donate oocytes during the trial or for approximately 6 months after the last dose of trial drug.
22. Male patient who is considering fathering a child or donating sperm during the trial or for approximately 12 months after the last dose of trial drug.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Phase 1 / Phase 2

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

17/05/2027

Actual

Date of last participant enrolment

Anticipated

30/01/2031

Actual

Date of last data collection

Anticipated

30/01/2033

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,SA,WA,VIC

Recruitment hospital [1]

Peter MacCallum Cancer Centre - Melbourne

Recruitment hospital [2]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [3]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [4]

St Vincent's Private Hospital - Fitzroy

Recruitment hospital [5]

Barwon Health - Geelong Hospital campus - Geelong

Recruitment hospital [6]

Calvary Mater Newcastle - Waratah

Recruitment hospital [7]

The Alfred - Melbourne

Recruitment hospital [8]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [9]

Royal North Shore Hospital - St Leonards

Recruitment hospital [10]

Box Hill Hospital - Box Hill

Recruitment hospital [11]

The Canberra Hospital - Garran

Recruitment hospital [12]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [13]

Sunshine Coast University Hospital - Birtinya

Recruitment hospital [14]

Royal Perth Hospital - Perth

Recruitment hospital [15]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

3000 - Melbourne

Recruitment postcode(s) [2]

3168 - Clayton

Recruitment postcode(s) [3]

3084 - Heidelberg

Recruitment postcode(s) [4]

3065 - Fitzroy

Recruitment postcode(s) [5]

3220 - Geelong

Recruitment postcode(s) [6]

2298 - Waratah

Recruitment postcode(s) [7]

6009 - Nedlands

Recruitment postcode(s) [8]

2065 - St Leonards

Recruitment postcode(s) [9]

3128 - Box Hill

Recruitment postcode(s) [10]

2605 - Garran

Recruitment postcode(s) [11]

4102 - Woolloongabba

Recruitment postcode(s) [12]

4575 - Birtinya

Recruitment postcode(s) [13]

6000 - Perth

Recruitment postcode(s) [14]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Australasian Leukaemia and Lymphoma Group

Address [1]

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

Australasian Leukaemia and Lymphoma Group

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Monash Health Human Research Ethics Committee A

Ethics committee address [1]

https://monashhealth.org/research/resources/resource-library/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/01/2027

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Title: AMLM28-A4. Achieving Durable remissions via Adaptive Pro-survival Targeting in Acute Myeloid Leukaemia (AML)-VEN/AZA/Lasmotinib: A therapeutic arm of the ALLG AMLM28 ADAPT study.

Purpose of this trial: 
This treatment arm is part of the AMLM28 ADAPT “platform” trial, where many treatment options are being explored for participants who are being treated with the standard of care (SOC) drugs Venetoclax (VEN) and Azacitidine (AZA). These participants are being treated with VEN-AZA because intensive chemotherapy is not considered an appropriate treatment option for them.
The goal is to find out if adding a new drug, lasmotinib, can help participants live longer without the disease returning or worsening. About 20% of newly diagnosed AML patients will have a gene mutation called FLT3-ITD. FLT3 is a gene that tells blood cells when to grow. FLT3-ITD is a mutation where the FLT3 gene has been duplicated, causing the gene to be permanently switched on and leukaemia cells to grow out of control. Lasmotinib works by blocking this signal, helping to slow the growth of the leukaemia cells and improve disease control.

Who is this trial for?
You may be eligible for this trial if you are:
•	A newly diagnosed AML patient enrolled on the AML28 ADAPT trial.
•	Eligible to receive SOC VEN-AZA treatment
•	 Have an abnormality on a specific gene, FLT3-ITD.
•	 Have been tested for another gene called NPM1.  

Trial details:
A4 treatment arm: There will be 12 cycles of treatment, with each cycle lasting for 28 days. Azacitidine is given either as an injection under the skin or through a vein for 7 days. Venetoclax is taken orally once a day for 21-28 days. 
This study will begin with a small group of participants (n=12) to find the safest dose of lasmotinib that can be added to SOC VEN-AZA treatment. Lasmotinib is taken orally once a day from day 8-day 28. The study is then expanded to recruit an additional 60 patients for a total of 72 patients in Australia only. 

Participants will be randomised to either receive SOC VEN-AZA or VEN-AZA with lasmotinib. If a participant is benefiting from treatment and wants to continue treatment past 12 cycles, this can be requested. Participants will be followed up for a year, every 3 months, after they have completed 12 cycles of treatment. Long term follow up data will be captured through the ALLG National Blood Cancer Registry (NBCR). 

This new approach could lead to better, more personalised treatment for people with AML who can’t have intensive chemotherapy. It aims to improve long-term outcomes and change how AML is treated in Australia.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Chyn Chua

Address

Monash Medical Centre, 246 Clayton Road, Clayton VIC 3168

Country

Australia

Phone

+61 3 9594 4365

Fax

[email protected]

Contact person for public queries

Name

Delaine Smith

Address

ALLG 35 Elizabeth St Richmond Vic 3121

Country

Australia

Phone

+61 3 8373 9701

Fax

[email protected]

Contact person for scientific queries

Name

Delaine Smith

Address

ALLG 35 Elizabeth St Richmond Vic 3121

Country

Australia

Phone

+61 3 8373 9701

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Anyone

• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• De-identified individual participant data:
• Published results

What types of analyses could be done with individual participant data?

• This will be reviewed on a case by case basis

When can requests for individual participant data be made (start and end dates)?

From:
3 months after publication

To:
No end date

Where can requests to access individual participant data be made, or data be obtained directly?

• Data sharing request system: Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health/). Search for the ACTRN number in the catalogue to find datasets associated with this trial or email enquiries to [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Study protocol			[email protected]	Access can be requested via the Health Data Austra... [More Details]

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

Trial Review

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