A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

Launched by BLOSSOMHILL THERAPEUTICS · Jul 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BH-30236 for patients with relapsed or refractory acute myelogenous leukemia (AML) and higher-risk myelodysplastic syndrome (HR-MDS). The trial aims to determine how safe the drug is, how well it works, and the best doses to give. This is an early-phase study, which means it’s one of the first times this medication is being tested in people. In the first part of the trial, researchers will enroll about 50 participants to assess safety and effectiveness. If the results are promising, the trial will expand to include up to 24 more participants to gather more detailed information about the drug's effects.

To be eligible for this trial, participants need to be at least 18 years old and have a diagnosis of relapsed or refractory AML or higher-risk MDS. They should have had previous treatments for their condition and have certain blood test results that show their organs are functioning well. It's important to note that individuals with specific types of leukemia or other serious health issues may not qualify. Participants will take the study drug by mouth and will be closely monitored by the research team throughout the trial to ensure their safety and to track how well the drug is working. If you or a loved one are considering participating, this could be an opportunity to access a new treatment option while contributing to important research.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • ≥18 years.
• • Diagnosis of relapsed/refractory acute myelogenous leukemia (R/R) AML or higher-risk myelodysplastic syndrome (HR-MDS) with ≥5% bone marrow blast at time of inclusion.
• • Prior treatment history must include 1-5 prior lines of therapy.
• • ECOG performance status ≤2.
• * Adequate organ function evidenced by the following laboratory values:
• • Hepatic: Transaminase levels aspartate aminotransferase \[AST\]/ alanine transaminase \[ALT\] ≤ 2.5 × upper limit of normal (ULN). In cases of liver involvement by AML or MDS, AST and ALT \< 5.0 × ULN is acceptable. Total bilirubin ≤ 1.5 × ULN in the absence of documented Gilbert's disease.
• • Renal: Measured or calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)
• • The above are a summary, other inclusion criteria details may apply.
• Exclusion Criteria:
• • Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast crisis.
• • Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of start of therapy;
• • Active and uncontrolled infections.
• • Unresolved AEs greater than Grade from prior therapies.
• • History of other active malignancy (with certain exceptions)
• • Prior treatment with a CLK inhibitor.
• • Any acute or chronic graft versus host disease requiring systemic therapy within 4 weeks prior to study drug administration with the exception of topical steroids or the equivalent of 20 mg of prednisone or less.
• • The above is a summary, other exclusion criteria details may apply.