急性骨髄性白血病（AML）を有する日本人成人患者を対象とした、経口ベネトクラクス錠と皮下低用量シタラビン（LDAC）注射剤の併用による有害事象の評価に関する研究

基本情報

NCT ID

NCT04509622

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

14

治験依頼者名

AbbVie

概要

Acute Myeloid Leukemia (AML) is a cancer of the white blood cells which perform many functions, including fighting bacterial infections and defending the body against parasites. This study will evaluate how safe venetoclax is and assess the adverse events in adult participants with AML. Venetoclax in combination with low-dose cytarabine (LDAC) is an approved therapy in the United States for patients with newly diagnosed acute myeloid leukemia (AML) aged \> 18 years with a medical condition that prevents the use of intensive chemotherapy. This study provides access to venetoclax in combination with LDAC to participants over 18 years who are ineligible for intensive induction therapy. Around 38 adult participants with diagnosis of AML will be enrolled in approximately 15 sites across Japan. Participants will receive oral venetoclax tablets once daily on days 1-28 in combination with subcutaneous low-dose cytarabine (LDAC) injections once daily on days 1-10 of the 28-day treatment cycles. Participants will attend regular visits during the study at a hospital to evaluate safety by medical assessments and blood tests.

対象疾患

介入

依頼者（Sponsor）

実施施設 (16)