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A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS

RecruitingPhase 1Ages 18 Years - anyAllApollo Therapeutics Ltd
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In plain words

What the trial is, and whether it could suit you

This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 18 years or older * Confirmed diagnosis of relapsed refractory 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. * WBC count โ‰ค 25,000/microliter * ECOG Performance Status of โ‰ค 2 * Weight โ‰ฅ 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
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What it tests

  • APL-4098
  • Azacitidine and APL-4098
  • Azacitidine and Venetoclax and APL-4098
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Where

9 sites
Monash Health
Clayton, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Australia
The Alfred Hospital
Melbourne, Australia
Hollywood Private Hospital
Nedlands, Australia
Royal Perth Hospital
Perth, Australia
University Hospital of Wales
Cardiff, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
The Royal Marsden Hospital
London, United Kingdom

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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