Maintenance Treatment With Imetelstat in Patients With High-Risk Myeloid Neoplasms After Allo-SCT

Korábbi kezelés

• Participants with available post SCT maintenance therapy, such as FLT3-ITD mutated AML or CML with TKIs, will be excluded unless these treatments cannot be given.

Más betegség

• Participants with active acute graft-versus-host disease (GVHD) Grade II-IV. Participants with controlled acute GVHD <grade II on stable dose steroid <=0.5mg/kg prednisone could be considered after discussion with study PI.
• Unstable cardiovascular function as listed below:
  • symptomatic ischemia
  • uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on antiarrhythmic agents are excluded; 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded)
  • congestive heart failure (CHF) NYHA Class ≥ 3
  • myocardial infarction (MI) within 3 months Note: Cardiovascular function testing (including echocardiogram) done as part of SCT screening. Consider repeat cardiac testing as standard of care if clinically indicated • Any medical condition which, in the investigator's opinion, could compromise the participant's safety

Laborértékek

• Treatment with any investigational agent within three weeks prior to first dose in this study. Concurrent donor lymphocyte infusion is not allowed while on the study. Participants on the study will be taken off the study in order to receive donor lymphocyte infusion.

• Age 18 - 80 years at the time of consent
• Participants with high-risk myeloid diseases after allo-SCT, including but not limited to the following:
• Intermediate- or high-risk acute myeloid leukemia ( AML) per European Leukemia Net (ELN) 2022 or ELN 2024 criteria
• Participants with myeloid malignancies that are minimal residual disease (MRD) positive by flow cytometry or other MRD tests; or with active disease (not in complete remission [CR]) prior to allo-SCT
• Intermediate, high- or very high-risk myelodysplastic syndromes (MDS) per Revised International Prognostic Scoring System (IPSS-R) or moderate high, high and very high-risk MDS per Molecular International Prognostic Scoring System (IPSS-M)
• Chronic myeloid leukemia (CML) in accelerated phase or myeloid blast phase
• Intermediate or high-risk primary myelofibrosis (PMF) by Dynamic International Prognostic Scoring System (DIPSS)-plus, Mutation-Enhanced International Prognostic Scoring System 70 (MIPSS-70)-plus version 2.0, or Myelofibrosis Secondary to Polycythemia Vera and Essential Thrombocythemia-Prognostic Model (MYSEC-PM) score
• Secondary myelofibrosis
• Primary myelofibrosis (PMF) in accelerated or blast phase
• Can be on immunosuppression drug(s)
• There is no morphologic evidence of disease relapse at the time of screening, and minimal residual disease (MRD) is acceptable.
• Karnofsky performance status of 60 or above or ECOG performance status <2.
• Able to sign informed consent