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An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.
Bu çalışma, IDH1 gen mutasyonu (R132) taşıyan, yeni tanı almış ve yoğun kemoterapiye uygun olmayan akut miyeloid lösemi (acute myeloid leukemia, AML) hastalarında Ivosidenib ilacının Azacitidine ile birlikte kullanımını değerlendirmektedir. Çalışmaya, daha önce AML tedavisi almamış, 75 yaş ve üzeri ya da yoğun kemoterapiye uygun olmayan yetişkin hastalar kabul edilmektedir. Faz 3 aşamasında yürütülmekte ve halen katılımcı almaktadır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Has untreated Acute Myeloid Leukemia (AML) * Have a documented IDH1 R132 gene-mutated disease * Have at least one of the following making yourself ineligible for intensive chemotherapy (IC): 75 years or older, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 2, or any comorbidity that the investigator judges to be incompatible with IC including but not limited to severe cardiac or pulmonary disorder, creatinine clearance less than 45 mL/minute, or bilirubin greater than 1.5 times the upper limit of normal * Has adequate hepatic (liver) and renal (kidney) function * Female participants of reproductive potential must have a negative blood pregnancy test and must use effective contraception during treatment and for at least 6 months following treatment * Fertile male participants with female partners of reproductive potential must use effective contraception during treatment and for at least 3 months following treatment Exclusion Criteria: * Has received any prior treatment for AML, with the exception of hydroxyurea or leukapheresis for white blood cell count control * Has received prior treatment with an IDH1 inhibitor * Is a woman who is pregnant or breastfeeding * 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 * Has had significant active cardiac disease within 6 months prior to the start of study treatment, including Class III or IV congestive heart failure, myocardial infarction (heart attack), unstable angina (chest pain), and/or stroke * Has dysphagia (difficulty swallowing), short-gut syndrome, gastroparesis (stomach paralysis), or any other condition that limits the ingestion or gastrointestinal absorption of orally administered drugs * Has uncontrolled hypertension (high blood pressure)