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再発性/難治性(R/R)急性骨髄性白血病(AML)の成人患者を対象とした、静脈内(IV)投与されたABBV-787の有害事象および動態を評価する試験

基本情報

NCT ID
NCT06068868
ステータス
中止
試験のフェーズ
第1相
試験タイプ
介入
目標被験者数
36
治験依頼者名
AbbVie

概要

Acute myeloid leukemia (AML) is the second most common type of leukemia diagnosed in adults and children, but most cases occur in adults. This study is to evaluate how safe ABBV-787 is and how it moves within the body in adult participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). Adverse events and maximum tolerated dose (MTD) of ABBV-787 will be assessed. ABBV-787 is an investigational drug being developed for the treatment of AML. Participants will receive ABBV-787 in escalating doses until the maximum tolerated dose (MTD) is determined. Approximately 60 adult participants with a diagnosis of AML will be enrolled worldwide. Participants will receive intravenous (IV) infusions of ABBV-787 during the approximately 3 year duration a participant is followed. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.

対象疾患

Acute Myeloid Leukemia

介入

ABBV-787(DRUG)

依頼者(Sponsor)

実施施設 (2)

国立研究開発法人国立がん研究センター中央病院

Kashiwa-shi, Chiba, Japan

国立大学法人山形大学医学部附属病院

Yamagata, Yamagata, Japan