A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission

  • Cancer
  • Leukemia
  • Acute Myeloid Leukemia
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Terminated

This trial runs in
Cities
  • Barcelona
  • Bergamo
  • Boston
  • Chicago
  • Columbus
  • Denver
  • Fairway
  • Houston
  • Iowa City
  • Los Angeles
  • Lyon
  • Madrid
  • Marseille
  • Melbourne
  • Meldola
  • Nantes
  • New York
  • Paris
  • Perth
  • Philadelphia
  • Sevilla
  • Toulouse
  • València
  • Winston-Salem
Trial Identifier:

NCT03850535 2018-002964-25 GO40800

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML).

      Hoffmann-La Roche Sponsor
      Phase 1/Phase 2 Phase
      NCT03850535,GO40800,2018-002964-25 Trial Identifier
      Idasanutlin, Cytarabine, Daunorubicin, Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT) Treatments
      Acute Myeloid Leukemia Condition
      Official Title

      A Phase Ib/II Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission

      Eligibility criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      Inclusion Criteria for All Study Phases:

      • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
      • Adequate hepatic and renal function
      • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs with a failure rate of <1% per year during the treatment period and for at least 6 months after the final dose of idasanutlin, cytarabine, or daunorubicin. Women must refrain from donating eggs during this same period.
      • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive, measures, and agreement to refrain from donating sperm that together result in a failure rate of <1% per year during the treatment period and for 6 months after the final dose of idasanutlin, cytarabine, or daunorubicin. Men must refrain from donating sperm during this same period.

      Inclusion Criteria for Patients in the Dose-Escalation and Expansion Phases:

      • Documented/confirmed newly diagnosed acute myeloid leukemia (AML) not previously treated according to World Health Organization (WHO)

      Inclusion Criteria for Patients in the Post-Consolidation Phase:

      • Documented/confirmed AML according to WHO in remission after induction, within 21 days of end of last chemotherapy consolidation cycle, and were minimum residual disease (MRD) positive at the end of induction as per local laboratory assessment
      Exclusion Criteria

      Exclusion Criteria for All Study Phases:

      • Clinical evidence of central nervous system (CNS) leukemia
      • Any Grade ≥2 non-hematologic toxicities prior to starting therapy
      • Current treatment with any other investigational or commercial agents or therapies administered with the intention to treat their malignancy with the exception of hydroxyurea (HU) or 6-mercaptopurine (6-MP)
      • Treatment-related AML
      • Acute promyelocytic leukemia
      • History of other malignancy that could affect compliance with the protocol or interpretation of results
      • Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, impair the ability of the investigator to evaluate the patient, or impair the patient's ability to complete the study
      • Echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan showing ejection fraction ≤40%
      • Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by this study treatment, such as hereditary coagulation disorders, insulin-dependent diabetes mellitus not optimally controlled with medical management (e.g., presence of ketoacidosis), or active GI conditions affecting absorption
      • Infection considered by the investigator to be clinically uncontrolled or of unacceptable risk to the patient upon the induction of neutropenia, that is, patients who are or should be on antimicrobial agents for the treatment of active infection
      • Febrile patients within 72 hours of study treatment initiation
      • Patients with a history of active or chronic infectious hepatitis unless serology demonstrates clearance of infection
      • Patients who are unable to interrupt treatment with moderate to strong CYP2C8 inducers and inhibitors
      • Patients who are unable to temporarily interrupt treatment with oral or parenteral anticoagulants/anti-platelet agents during treatment phase
      • Patients who have a history of clinically significant liver cirrhosis
      • Patients with extramedullary AML with no evidence of systemic involvement
      • Pregnant or breastfeeding patients
      • Known history of HIV-positive status
      • Patients who might refuse to receive blood products and/or have a hypersensitivity to blood products
      • Prior treatment with an MDM2 antagonist
      • Patients with clinically relevant QTc prolongation, a family history of long QT syndrome

      Exclusion Criteria for Patients in the Phase Ib Dose-Escalation Phase:

      • Adverse risk patients as per European LeukemiaNet (ELN) 2017 criteria

      Exclusion Criteria for Patients in Phase Ib Post-Consolidation Phase:

      • Any ongoing Grade ≥2 hematologic adverse events prior to starting therapy
      • Previous hematopoietic stem cell transplant (HSCT)

      Exclusion Criteria for Patients in the Dose-Escalation Phase and Patients in the Favorable/Intermediate-Risk Cohort of the Expansion Phase:

      • Secondary AML, defined as AML evolving from antecedent hematologic disorder (AHD)

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