The study of the new investigational drug for acute myeloid leukemia and myelodysplastic syndrome
PureTech is recruiting patients for the clinical trial of LYT-200 in patients with relapsed/refractory acute myeloid leukemia (AML), or with relapsed/refractory, high-risk myelodysplastic syndrome (MDS).
In Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), immature blood cells are overproduced, leading to less mature blood cells. This causes anaemia, with underlying increased risk for infection and bleeding (MD Anderson Cancer Center, 2023). Chemotherapy, radiation and/or autologous treatments are among possible causes of MDS or AML in up to 10% of patients.
No available therapies can currently cure most of patients suffering from MDS and AML, which calls for urgent development of new medicines.
This open-label, non-randomized, multi-center, phase 1, dose escalation study includes patients with AML relapsed/refractory to at least one line of prior therapy, with or without an allogeneic stem cell transplant, or in patients with a documented diagnosis of relapsed/refractory, high-risk myelodysplastic syndrome (MDS) post at least one line of treatment and for whom no standard therapy that may provide clinical benefit is available.
The study commenced on December 12, 2022. The indicative completion of the clinical trial will be expected on May 1, 2025.
Among primary outcome measures are the Incidence of Treatment-Emergent Adverse Events [Safety and RP2D determination] and Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, ECG, ECHO/MUGA, ECOG status.
The study will take place at several research sites in the United States: Baptist Health South Florida-Miami Cancer Institute, Miami; Cedars-Sinai Medical Center, Los Angeles; University of California Irvine Medical Center, Orange.
Among the inclusion criteria are
1. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2,
2. Patients are able and willing to comply with study procedures as per protocol, including bone marrowbiopsies,
3. 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 and
4. 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 can be enrolled into this research.
The page dedicated to this clinical trial that provides research sites contacts and more detailed information regarding the inclusion and the exclusion criteria can be found here: https://ichgcp.net/clinical-trials-registry/NCT05829226.