急性骨髄性白血病患者を対象に、アザシチジン皮下投与または静脈内投与とベネトクラクス経口投与を併用してレムゾパルリマブを静脈内投与した場合、および骨髄異形成症候群患者を対象に、アザシチジン単独またはベネトクラクス併用でレムゾパルリマブを静脈内投与した場合の有害事象および体内動態を評価する研究

基本情報

NCT ID

NCT04912063

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

40

治験依頼者名

AbbVie

概要

Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo intensive chemotherapy, the current standard of care. This study is to evaluate how safe lemzoparlimab is and how it moves within the body when used along with azacitidine and/or venetoclax in adult participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Adverse events and maximum tolerated dose (MTD) of lemzoparlimab will be assessed. Lemzoparlimab (TJ011133) is being evaluated in combination with azacitidine and venetoclax for the treatment of acute myeloid leukemia (AML) and with azacitidine with/without venetoclax for myelodysplastic syndrome (MDS). Study doctors place the participants in 1 of 5 groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of AML or MDS will be enrolled. Around 80 participants will be enrolled in the study in approximately 50 sites worldwide. Participants will receive lemzoparlimab (IV) once weekly (Q1W), venetoclax oral tablets once daily (QD) for 28 days (AML participants) or 14 days (MDS participants) and Azacitidine by SC or IV route QD for 7 days of each 28-day cycle. 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

介入

依頼者（Sponsor）

実施施設 (4)