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Clinical Studies


  • Assessment of frailty and clonal hematopoiesis in adults with hematological diagnosis Rochester, Minn.

    The purpose of this study is to assess the frailty and clonal hematopoiesis (CH) in hematology malignancy patients.

  • Cell, Serum, and Buccal Bank for Patients with Chronic Myeloid Disorders and Acute Leukemia Rochester, Minn.

    This study is being done to store blood, buccal (cheek) cells, genetic material including DNA (deoxyribonucleic acid) and RNA (ribonucleic acid), and bone marrow so that they can be used for laboratory studies that may contribute to finding the causes of disease and factors that may determine disease progression and treatment response.

  • KO-MEN-001, A Phase 1/2A First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO 539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to determine the maximum tolerated dose (MTD) of KO-539, a menin-MLL(KMT2A) inhibitor, in patients with refractory or relapsed  acute myeloid leukemia (AML) who have failed or are ineligible for any approved standard of care therapies, including hematopoietic stem cell transplantation (HSCT).

  • Methylation and Chromatin Abnormalities in Myelodysplastic Syndromes and Chronic Myelomonocytic leukemia. Rochester, Minn.

    The purpose of this study is to assess tumor cells from blood and bone marrow from patients with myeloid neoplasms for epigenetic dysregulation and abnormalities of chromatin and for immune activation and exhaustion.

  • Pre-myeloid Cancer and Bone Marrow Failure Clinic Study Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to test a new technology called Next Generation Sequencing (NGS) that may help identify this risk associated with precursor conditions and the likelihood that they will change into overt blood and bone marrow cancers. NGS is a procedure that looks at relevant cancer associated genes and what they do.

  • STML-401-0314 - Tagraxofusp (SL-401) in Patients with Chronic Myelomonocytic Leukemia (CMML) Rochester, Minn., Jacksonville, Fla.

    This is a non-randomized open label multi-center study. Patients with high-risk myeloproliferative neoplasms (systemic mastocytosis [SM], advanced symptomatic hypereosinoophic disorder [PED], myelofibrosis [MF], and chronic myelomonocytic leukemia [CMML]) will be treated with SL-401, which will be administered as a brief intravenous infusion for 3 consecutive days initially every 21 days for 4 cycles; every 28 days for cycles 5-7; then every 42 days. Stage 1 will consist of a period in which several doses of SL-401 are evaluated. The Stage 2 portion will enroll up to 18 patients with each of the 4 myeloproliferative malignancies: SM, PED, MF, and CMML. In entirety, the Stage 2 portion will consist of up to 72 patients who will be treated at a maximum tolerated dose or maximum tested dose in which multiple dose-limiting toxicities are not observed (identified in Stage 1).

Closed for Enrollment