A single arm, open-label Phase 3b study to describe the safety and tolerability of ivosidenib in combination with azacitidine in adult patients newly diagnosed with IDH1m acute myeloid leukemia (AML) ineligible for intensive induction chemotherapyALIDHE - DIM-95031-006

Servier Affaires Medicales0 个研究点目标入组 233 人开始时间: 2022年12月19日最近更新: 2024年7月22日

试验速览

阶段: 1 期
状态: 招募中
发起方: Servier Affaires Medicales
入组人数: 233

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Has previously untreated AML, defined according to the 2022 ELN Recommendations for AML or the International Consensus Classification of myeloid neoplasms and acute leukemia, Be =18 years of age and meet at least one of the following criteria defining ineligibility for IC: a. =75 years old b. ECOG PS =2 c. Any comorbidity that the Investigator judges to be incompatible with IC, including: i. Severe cardiac disorder ii. Severe pulmonary disorder iii. Creatinine clearance <45 mL/minute iv. Bilirubin >1.5 times upper limit of normal (× ULN) v. Any other comorbidity that the Investigator judges to be incompatible with IC as documented before study enrolment., Has documented R132 IDH1m based on local biomolecular profiling method, Has an ECOG =2., Has adequate hepatic function as evidenced by Child-Pugh class A or B, Has adequate renal function, as described in the protocol, Willing to voluntarily provide written, signed, and dated informed consent.

排除标准

•Has received any prior treatment for AML with the exception of hydroxyurea or leukapheresis for white count control, Has a prior history of malignancy other than MDS or myeloproliferative disorder under active treatment. However, a patient with the following history/concurrent conditions or similar indolent cancer are allowed to participate in the study: a. Basal or squamous cell carcinoma of the skin b. Carcinoma in situ of the cervix c. Carcinoma in situ of the breast d. Incidental histologic finding of prostate cancer, Has had significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, and/or stroke, Has dysphagia, short-gut syndrome, gastroparesis, or any other condition that limits the ingestion or gastrointestinal absorption of orally administered drugs, Has immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, organ failure and/or disseminated intravascular coagulation, Has extramedullary disease alone (i.e., no detectable bone marrow and no detectable peripheral blood AML), Has previously received treatment for an antecedent hematologic disorder, including investigational agents, may not be enrolled until a washout period of =5 half-lives of the investigational or standard of care agent have elapsed since the last dose of that agent (Note: previous treatment with HMA for MDS is allowed), Has received prior treatment with an IDH1 inhibitor, Has a known hypersensitivity to any of the components of ivosidenib or azacitidine, Is a woman who is pregnant or breastfeeding, Is taking known strong cytochrome P450 (CYP) 3A4 inducers, inhibitors or sensitive CYP3A4 substrate medications with a narrow therapeutic window, unless they can be transferred to other medications or unless the patient can be properly monitored during the study, Is taking P-glycoprotein (P-gp) transporter-sensitive substrate medications or inhibitors unless they can be transferred to other medications or unless the patient can be properly monitored during the study, Has an active, uncontrolled, systemic fungal, bacterial, or viral infection (including human immunodeficiency virus [HIV], active hepatitis B (HBV), or hepatitis C virus [HCV]) without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.

研究者

发起方

Servier Affaires Medicales

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