Phase 2 Leukaemia Trial, Recruiting (NCT06456463)

Phase 2 Leukaemia Trial, Recruiting NCT06456463 Sponsor: Stemline Therapeutics, Inc. Condition: Leukaemia

Printed from Voxsanity (voxsanity.com.au) — NCT06456463 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Leukaemia

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

You have been newly diagnosed with a type of blood cancer called AML (acute myeloid leukemia) that has been confirmed by a lab test, and you have not yet received any treatment for it.
Your AML cells have any level of a protein called CD123 on their surface (confirm with trial site).
You are 75 years of age or older, OR you are between 18 and 74 years old and are considered too unwell for strong chemotherapy for at least one of the following reasons:
- Your general health and ability to carry out daily activities is significantly limited (confirm with trial site).
- Your lungs do not function at full capacity, based on breathing tests (confirm with trial site).
- Your kidneys are not working at full capacity, based on a blood or urine test (confirm with trial site).
- Your liver is not working properly, shown by elevated levels in a blood test (confirm with trial site).
- Your doctor believes you are not suitable for intensive chemotherapy for another medical reason.
Your general health and daily functioning meets certain requirements depending on your age (confirm with trial site).

Who may not be able to join:

You have already received any treatment specifically for AML.
You are willing and able to receive the standard intensive chemotherapy treatment for AML.
You have previously been treated for a related blood disorder using certain specific medicines or therapies, including stem cell transplant or experimental treatments (confirm with trial site).
Your AML has spread to your brain or spinal cord.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 5 July 2026

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1-877-332-7961

Australian sites

Concord Repatriation General Hospital, Concord, New South Wales

Townsville Hospital, Douglas, Queensland

Royal Adelaide Hospital, Adelaide, South Australia

Box Hill Hospital, Box Hill, Victoria

Monash Medical Centre, Clayton, Victoria

St. Vincents Hospital, Fitzroy, Victoria

Austin Hospital, Heidelberg, Victoria

Royal Perth Hospital, Perth, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT06456463

Sponsor: Stemline Therapeutics, Inc.

Phase: Phase 2

Status: Recruiting

Condition: Leukaemia

Trial contact: 1-877-332-7961

More information: https://clinicaltrials.gov/study/NCT06456463

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have been newly diagnosed with a type of blood cancer called AML (acute myeloid leukemia) that has been confirmed by a lab test, and you have not yet received any treatment for it.
Your AML cells have any level of a protein called CD123 on their surface (confirm with trial site).
You are 75 years of age or older, OR you are between 18 and 74 years old and are considered too unwell for strong chemotherapy for at least one of the following reasons:
- Your general health and ability to carry out daily activities is significantly limited (confirm with trial site).
- Your lungs do not function at full capacity, based on breathing tests (confirm with trial site).
- Your kidneys are not working at full capacity, based on a blood or urine test (confirm with trial site).
- Your liver is not working properly, shown by elevated levels in a blood test (confirm with trial site).
- Your doctor believes you are not suitable for intensive chemotherapy for another medical reason.
Your general health and daily functioning meets certain requirements depending on your age (confirm with trial site).

Who may not be able to join:

You have already received any treatment specifically for AML.
You are willing and able to receive the standard intensive chemotherapy treatment for AML.
You have previously been treated for a related blood disorder using certain specific medicines or therapies, including stem cell transplant or experimental treatments (confirm with trial site).
Your AML has spread to your brain or spinal cord.

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 5 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 2

Sponsor

Stemline Therapeutics, Inc.

Registry

ClinicalTrials.gov

Start date

14 January 2025

Est. completion

9 February 2028

Where this trial is recruiting

🇦🇺 Australia 🇺🇸 United States

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part 1: Determination of Part 2 Selected Dose of Tagraxofusp When Administered in Combination with Venetoclax and Azacitidine; Part 2: Number of Participants Achieving a Best Overall Response (BOR) of Complete Remission (CR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 5 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov