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

  • STATUS
    Recruiting
  • End date
    Jul 15, 2024
  • participants needed
    86
  • sponsor
    Kartos Therapeutics, Inc.
Updated on 10 September 2021
cancer
cytarabine
decitabine
refractory acute myeloid leukemia (aml)

Summary

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination 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 monotherapy (KRT-232 alone) or combination therapy (KRT-232 with LDAC or KRT-232 with Decitabine).

Details
Condition Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN), anll, Relapsed or Refractory Acute Myeloid Leukemia, acute myeloblastic leukemia, Acute Myeloid Leukemia, Acute Myelogenous Leukemia (AML), Acute myeloid leukemia, acute myelogenous leukemia
Treatment cytarabine, Decitabine, KRT-232
Clinical Study IdentifierNCT04113616
SponsorKartos Therapeutics, Inc.
Last Modified on10 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Part A: Patients with relapsed or refractory AML, or newly-diagnosed AML secondary to MPN
Part B:Patients with relapsed or refractory AML secondary to MPN (myelofibrosis [MF], polycythemia vera [PV], or essential thrombocythemia [ET]); patients may have been treated with 1 prior lines of therapy for their AML secondary to MPN
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 (for Part A)
Patients previously treated with decitabine are not eligible to receive decitabine on this study but may be treated with cytarabine (for Part A)
Patients who have received an allogeneic HSCT within 90 days of enrollment or who have active graft-versus-host disease requiring active therapy (for Part A)
Allogeneic stem cell transplant within 3 months; autologous stem cell transplant within 3 months or active graft-versus-host disease prior to first dose of study treatment (for Part B)
Patients who have received immunosuppressive therapy for graft-versus-host disease within 1 month prior to enrollment into this study
Patients with known CNS involvement with AML, acute promyelocytic leukemia (APL), or a history of bleeding diathesis
Patients who are eligible for an allogeneic HSCT per the opinion of the investigator and have a donor. Patients who are HSCT-eligible in the opinion of the investigator, but who refuse a transplant, are eligible for the study
Women who are pregnant or breastfeeding
Patients who have had major surgery within 28 days prior to the first treatment with KRT-232
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