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  • A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial) Rochester, Minn. This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
  • A Phase I/II Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Efficacy of ONO-7475 in Patients With Acute Leukemias or Myelodysplastic Syndromes (ONO-7475-01) Jacksonville, Fla.

    The purpose of this study is to assess the safety and tolerability of ONO-7475 monotherapy in patients with relapsed or refractory acute myeloid leukemia or relapsed or refractory myelodysplastic syndromes, and to assess the safety, tolerability, and preliminary effectiveness of the combination of ONO-7475 and venetoclax in patients with relapsed or refractory acute myeloid leukemia.

  • CC-96191-AML-001: A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-96191 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia Rochester, Minn.

    The purpose of this study is to explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML). The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy. The expansion (Part B), will further evaluate the safety and effectiveness of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.

  • 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).

  • SLSG18-301: A Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S (GPS) Maintenance Monotherapy Compared to Investigator's Choice of Best Available Therapy in Subjects with Acute Myeloid Leukemia Who Have Achieved Complete Remission After Second-Line Salvage Therapy Jacksonville, Fla.

    This is an open-label, multicenter, randomized, parallel groups study of GPS vs. best

    available treatment (BAT) in patients with AML in second complete remission (CR2)

    or in second complete remission with incomplete platelet recovery (CRp2). All

    patients will have their historical bone marrow samples stained for WT1 via IHC by

    central pathology review. The primary goal of the study will be to demonstrate an

    advantage for GPS in overall survival in these patient populations. The study will

    enroll approximately 116 patients and will be conducted at up to 50 investigational

    sites. Patients will be randomized 1:1 to GPS or BAT stratified by whether they are

    in CR2 or CRp2.

    Patients on the BAT arm may be treated with 1. observation (whereby palliative

    management with hydroxyurea is allowed), 2. a hypomethylating agent (decitabine or

    azacitidine), and/or 3. Venetoclax and/or 4. low-dose ara-C. Patients whose

    remission in CR2 that can be maintained with other agents (e.g. FLT-3 or IDH

    inhibitors) will not be eligible. However, there are no restrictions on prior use of

    any agents in the CR1 setting. Patients can not receive GPS as an adjunct therapy to

    any other agents.

    Patients on the GPS arm will receive 70 μg of sargramostim (GM- CSF) on Day -2

    and Day 1 before each injection of GPS. The first two administrations of GM-CSF

    will take place at the same anatomical site as the planned administration of GPS within

    each treatment cycle. GPS will be administered as an immunization induction every

    2 weeks for 6 administrations (Weeks 0 – 10); this will be followed by a 4-week

    period of no treatment. Treatment will then resume for 6 administrations as an initial

    booster phase every 4 weeks (Weeks 14 – 34) which will again be followed by a

    period of no treatment lasting 6 weeks. GPS will be resumed after this period as a

    second booster phase and will be administered every 6 weeks for 3 administrations

    (Weeks 40 – 52). Following each administration of GM-CSF or GPS, patients will

    remain in the clinic for approximately 30 minutes for observation. An End of

    Treatment visit will be conducted 30 days following the last dose of GPS. Patients

    will then enter the long-term follow-up portion of the trial where they will be followed

    for recurrence of leukemia and overall survival.

    To ensure a comparable level of observation, patients randomized to the BAT arm

    will be seen every 4 weeks through Week 52. The Schedules of Procedures for both

    the GPS and the BAT arms can be found in Section 6 of the protocol.

    All patients will undergo bone marrow aspirates and biopsies at screening, Week 12

    and end of treatment. Bone marrow examinations will then be repeated as clinically

    indicated. Patients will be assessed for safety at each clinic encounter. The primary

    endpoint will be overall survival.

Closed for Enrollment

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