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)
Completed · Phase 1
Conditions studied: AML, Adult Recurrent, MDS
In brief
A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), or with Relapsed/refractory, High-risk Myelodysplastic Syndrome (MDS)
Key facts
- Study ID
- NCT05829226
- Run by
- PureTech
- People needed
- 101
- Starts
- 2022-12-12
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- University of California Irvine Medical Center — Orange, California, United States
- Baptist Health South Florida-Miami Cancer Institute — Miami, Florida, United States
- Norton Healthcare-Norton Cancer Institute — Louisville, Kentucky, United States
- Mass. General Hospital-Harvard — Boston, Massachusetts, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
- Virginia Commonwealth University Medical Center — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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