Investigating APL-4098 with Azacitidine for treating relapsed or refractory AML and high-risk MDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase 1/2 study aims to evaluate the safety, tolerability, and efficacy of APL-4098, both alone and in combination with azacitidine, for patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with excess blasts. The study will include participants who are intolerant to or ineligible for existing therapies. The Phase 1 portion will specifically focus on patients with the MDS-excess blasts subtype. The trial will assess various outcomes to determine the potential benefits of this treatment regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 years or older
* Confirmed diagnosis of acute myeloid leukemia (R/R AML), myelodysplastic syndrome (MDS)/ AML, or MDS-excess blasts (MDS-EB) with the following characteristics: R/R AML (primary or secondary, including treatment-related), participant is intolerant to, or considered ineligible for available therapies known to provide clinical benefit; Newly diagnosed (ND AML), previously untreated, and considered unfit for available front line therapies or standard intensive chemotherapy.
* WBC count ≤ 25,000/microliter
* ECOG Performance Status of ≤ 2
* Weight ≥ 40kg
* Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse
* Male participants must be willing to use specific contraception and not plan to impregnant a female partner or donate sperm while on study
* Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial

Exclusion Criteria:

* Certain prior therapies such as: received an allogeneic stem cell transplant within 6 months of screening, received an autologous stem cell transplant within 3 months of screening, received any anti-cancer treatments within 2 weeks of Cycle 1 Day 1, prior radiation therapy within 4 weeks of screening
* Certain medical conditions such as: other malignancies, myocardial infarction within 6 months of screening, symptomatic congestive heart failure, uncontrolled active infection, history of arterial thrombosis within 6 months of screening
* Diagnostic assessments: Left ventricular ejection fraction \< 45%, Fridericia's corrected QT interval \> 470msec, Aspartate aminotransferase and/or alanine aminotransferase \> 3 x upper limit of normal (ULN), total bilirubin \> 1.5 x ULN, calculated or measured creatinine clearance \< 45 mL/minute (multiply by 0.85 if female)
* Infectious disease: HIV positive, active hepatitis B and/or C

Where it's running

• Monash Health
  Clayton, Victoria, Australia Recruiting
• St. Vincent's Hospital Melbourne
  Fitzroy, Victoria, Australia Recruiting
• The Alfred Hospital
  Melbourne, Victoria, Australia Recruiting
• Royal Perth Hospital
  Perth, Western Australia, Australia Recruiting
• University Hospital of Wales
  Cardiff, United Kingdom Recruiting
• Beatson West of Scotland Cancer Centre
  Glasgow, United Kingdom Recruiting

Study contacts

• Study coordinator: Apollo Therapeutics
• Email: AP30@apollotx.com
• Phone: 781-479-2267

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.