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

Stopped early · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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).

Key facts

Study ID

NCT03850535

Run by

Hoffmann-La Roche

People needed

24

Starts

2019-03-25

Expected to finish

2020-09-10

Last updated by the study team

2022-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:

Where it is running

• UCLA Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics; Investigational Drug Services — Iowa City, Iowa, United States
• University of Kansas Clinical Research Center; Clinical Trials Office — Fairway, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• State University of NY — Brooklyn, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• The Alfred Hospital — Prahan, Victoria, Australia
• Royal Perth Hospital — Perth, Western Australia, Australia
• Centre Léon Bérard — Lyon, France
• Institut Paoli Calmettes — Marseille, France
• CHU de Nantes - Hotel Dieu — Nantes, France
• Hôpital Saint-Louis — Paris, France
• Institut Universitaire du Cancer de Toulouse-Oncopole — Toulouse, France
• Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia — Meldola, Emilia-Romagna, Italy
• ASST Papa Giovanni XXIII; Dipartimento Interaziendale di Farmacia Clinica — Bergamo, Lombardy, Italy
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
• Hospital Universitario Vall d'Hebron — Barcelona, Spain
• Hospital Universitario Fundacion Jimenez Diaz. — Madrid, Spain
• Hospital Universitario Virgen del Rocío; Servicio de Neuropediatra — Seville, Spain

Full record on ClinicalTrials.gov

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