Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML

Launched by STELEXIS BIOSCIENCES · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called eganelisib, both on its own and in combination with another medication called cytarabine. The focus is on patients with relapsed or refractory acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (HR-MDS), which means their cancer has come back or did not respond to previous treatments. The trial aims to find out how safe and effective eganelisib is, as well as how the body processes the drug.

To participate, patients need to have a confirmed diagnosis of AML or HR-MDS with a certain level of cancer cells in their bone marrow. They should also be in relatively good health, with specific criteria regarding their overall condition and organ function. Important to note, patients who have recently had a stem cell transplant or are on certain medications may not be eligible. While the trial is not yet recruiting participants, those who join can expect close monitoring and support throughout their treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Pathological diagnosis of either: AML according to World Health Organization (WHO) 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts (acute promyelocytic leukemia is excluded but secondary AML and treatment-related AML can be included); Higher-risk (IPSS-R Intermediate, High or Very High Risk at time of study entry) myelodysplastic syndromes (HR-MDS) according to WHO 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts.
• • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• • Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib.
• Exclusion Criteria:
• • Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1.
• • Receiving immunosuppressants (eg, cyclosporin) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency).
• • Active fungal disease or uncontrolled infection of any kind; patients receiving antibiotic, antifungal or antiviral treatment must be afebrile and hemodynamically stable for \>72 hours prior to treatment
• • WBC count \>25 × 10\^9/L measured within 7 days prior to the first dose of eganelisib (hydroxyurea is permitted to decrease the WBC count).
• • Presence of a clinically significant non-hematologic toxicity of prior therapy that has not resolved to Grade ≤1 or Baseline, whichever is worst, as determined by NCI CTCAE v 5.0, except alopecia or skin pigmentation. Fatigue and neuropathy must have resolved to Grade ≤2.