A Study to Investigate APL-4098 Alone and/or in Combination With Azacitidine in R/R AML and High-Risk MDS

Launched by APOLLO THERAPEUTICS LTD · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called APL-4098, both on its own and combined with another medication called azacitidine. The goal is to see how safe and effective these treatments are for adults with relapsed or refractory acute myeloid leukemia (a type of blood cancer that doesn't respond to standard treatments) and myelodysplastic syndrome (a condition where the bone marrow doesn't make enough healthy blood cells). The trial is currently recruiting participants who are at least 18 years old and have been diagnosed with these conditions. To qualify, participants need to have certain health criteria, including a specific white blood cell count and overall health status.

If you join the trial, you will be closely monitored by medical professionals throughout the study. Participants will receive APL-4098 and potentially azacitidine, and doctors will track how well these medications work and any side effects they may cause. It's important to note that there are specific health conditions and prior treatments that could exclude someone from participating, so a thorough screening will take place. Overall, this trial offers an opportunity to explore new treatment options for patients with difficult-to-treat blood cancers.

Gender

ALL

Eligibility criteria

• 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 ≤ 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 we 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