A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)

Launched by PURETECH · Apr 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LYT-200 for adults with relapsed or refractory Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS). In simple terms, this means the trial is looking for ways to help patients whose cancer has not responded to previous treatments or who have a serious form of blood cancer that has come back after treatment. The trial is open to patients aged 18 and older who meet certain health criteria, including those who have tried at least one prior treatment without success.

Participants in this study can expect to receive the new treatment while doctors closely monitor their health to understand how safe it is and how well it works. They will need to undergo some tests, including bone marrow biopsies, to check their progress. It’s important to know that this is a Phase 1 study, which means it's one of the first steps in testing this treatment in people, focusing mainly on safety. If you or someone you know is considering joining this trial, it’s a chance to potentially access a new treatment option when other standard therapies are not available.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients ≥ 18 years of age at the time of obtaining informed consent.
• • Patients with morphologically documented primary or secondary AML by the World Health Organization(WHO) criteria, whose disease is relapsed/refractory to at least one line of prior therapy, with or without an allogeneic stem cell transplant and for whom no standard therapy that may provide clinical benefit is available or for patients who decline available standard of care.
• • Patients with a documented diagnosis of high-risk myelodysplastic syndrome (MDS), whose disease is relapsed/refractory, post at least one line of treatment based on the revised International Prognostic Scoring System (IPSS-R) and for whom no standard therapy that may provide clinical benefit is available
• • Patients are able and willing to comply with study procedures as per protocol, including bone marrowbiopsies.
• • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• * Patient must meet the following criteria as indicated on the clinical laboratory tests:
• • oWhite blood cell (WBC) count at the time of the first dose of \< 25,000/uL. oAspartate aminotransferase or alanine aminotransferase ≤ 3 × upper limit of normal (ULN; ≤ 5.0× ULN if considered to be due to leukemic involvement). oTotal bilirubin ≤ 2 × ULN (≤ 3 × ULN if considered to be due to leukemic involvement orGilbert's syndrome). oCreatinine clearance of ≥ 60 mL/min.
• Exclusion Criteria:
• • Patient diagnosed with acute promyelocytic leukemia (APL).
• • Patient has active malignant tumors other than AML/MDS
• • Patient has had HSCT and meets any of the following: has undergone HSCT within the 6- month period prior to the first study dose; has ≥ Grade 2 persistent non-hematological toxicity related to the transplant donor lymphocytes infusion.
• • Patient has active graft versus host disease (GVHD) and patients receiving immunosuppressive treatment for GVHD.
• • Patient with symptomatic central nervous system (CNS) involvement of leukemia or other CNS diseases related to underlying and secondary effects of malignancy
• • Patient has had major surgery within 4 weeks prior to the first study dose.
• • Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%.
• • Patient has any condition which, in the Investigator's opinion, makes the patient unsuitable for study participation.