AML and MDS: Lemzoparlimab (TJ011133) in Combination with Azacitidine
Research type
Research Study
Full title
A Phase 1b Dose Escalation Study of Lemzoparlimab in Combination with Venetoclax and/or Azacitidine in Subjects with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
IRAS ID
303933
Contact name
Emma Searle
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2021-000514-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 10 days
Research summary
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 subcutaneously or intravenously QD for 7 days of each 28-day cycle.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0129
Date of REC Opinion
27 Jun 2022
REC opinion
Further Information Favourable Opinion