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)

  • STATUS
    Recruiting
  • End date
    Jul 15, 2024
  • participants needed
    160
  • sponsor
    Kartos Therapeutics, Inc.
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Updated on 27 January 2021
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cancer
cytarabine
decitabine
refractory acute myeloid leukemia (aml)

Summary

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.

Details
Condition Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN), Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN), Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN), Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN), Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN), Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN), Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN), acute myelogenous leukemia, anll, acute myeloblastic leukemia, Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN), Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN), Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN), Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN)
Treatment cytarabine, Decitabine, KRT-232
Clinical Study IdentifierNCT04113616
SponsorKartos Therapeutics, Inc.
Last Modified on27 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Acute myeloid leukemia or Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN) or Acute Myelogenous Leukemia (AML)?
Do you have any of these conditions: acute myeloblastic leukemia or anll or Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN) or Acute myeloid leukemia or Acut...?
Do you have any of these conditions: Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN) or anll or acute myeloblastic leukemia or Acute Myelogenous Leukemia (AM...?
Do you have any of these conditions: Acute myeloid leukemia or acute myelogenous leukemia or Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN) or Acute Myeloge...?
Do you have any of these conditions: acute myelogenous leukemia or anll or Acute myeloid leukemia or Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN) or Acute...?
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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