Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome

Study Identifier
M20-866
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
For general inquiries, please contact

Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
  • Blood Cancer - Other
  • Study Drug
  • Lemzoparlimab
  • Azacitidine
  • Venetoclax
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol 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 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.

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham - Main /ID# 227071
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Norton Cancer Institute - St Matthews /ID# 228378
    Louisville, Kentucky, United States, 40207
    Status
    Not applicable
    Location
    Massachusetts General Hospital /ID# 227273
    Boston, Massachusetts, United States, 02114
    Status
    Not applicable
    Location
    Beth Israel Deaconess Medical Center /ID# 231083
    Boston, Massachusetts, United States, 02215-5400
    Status
    Not applicable
    Location
    University of Michigan /ID# 227030
    Ann Arbor, Michigan, United States, 48109
    Status
    Not applicable
    Location
    University of Pennsylvania /ID# 227024
    Philadelphia, Pennsylvania, United States, 19104
    Status
    Not applicable
    Showing {first} - {last} of {total} Results