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An Open-Label, Multicenter, Phase 1b / 2 Study of the Safety and Efficacy of KRT-232 Combined With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)

Trial Status: Active

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed / refractory (having failed prior therapy) and will be assigned to receive KRT+232 with LDAC or KRT-232 with Decitabine.

Inclusion Criteria

  • Part A: Patients with relapsed or refractory AML, or newly-diagnosed AML secondary to MPN
  • Part B: Patients with AML secondary to MPN or JAK2 mutation positive AML; patients may have been treated with 0 to 2 prior lines of therapy for their AML
  • Adequate hepatic and renal function
  • Appropriate prior treatment with an FLT3 or IDH1/2 inhibitor where applicable

Exclusion Criteria

  • Patients who are TP53 mutation positive
  • Prior treatment with an MDM2 antagonist therapy
  • Patients treated with ≥ 18 g/m2 of cytarabine within the prior 90 days are not eligible to be treated with cytarabine on this study (but may be treated with decitabine)
  • Patients previously treated with decitabine are not eligible to receive decitabine on this study (but may be treated with cytarabine)
  • Patients who have received an allogeneic HSCT within 90 days of enrollment or are eligible for an allogeneic HSCT and have a donor (unless transplant is refused)
  • Active graft-versus-host disease requiring active therapy or who have received immunosuppressive therapy for graft-versus-host disease within 1 month prior
  • Patients with known CNS involvement with AML, acute promyelocytic leukemia (APL), or a history of bleeding diathesis
  • Patients who have had major surgery within 28 days prior
  • Women who are pregnant or breastfeeding

Illinois

Chicago
Northwestern University
Status: ACTIVE
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE

New York

New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Raajit Kumar Rampal
Phone: 212-639-2194

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Kartos Therapeutics, Inc.

  • Primary ID KRT-232-104
  • Secondary IDs NCI-2019-07064
  • Clinicaltrials.gov ID NCT04113616