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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT04912063
Phase
PHASE1
Status
Terminated

Conditions

  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndrome (MDS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lemzoparlimab — DRUG
    Intravenous (IV) Infusion
  • Azacitidine — DRUG
    Subcutaneous Injection or Intravenous (IV) Injection/Infusion
  • Venetoclax — DRUG
    Oral Tablet

Study Details

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.

Key Dates

Start date
Jun 25, 2021
Status verified
Feb 2024
Primary completion
May 9, 2023
Completion
May 9, 2023

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Lemzoparlimab + Azacitidine + Venetoclax in AML (Escalation)
    Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in escalated doses in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.
  • Experimental: Lemzoparlimab + Azacitidine + Venetoclax in MDS (Escalation)
    Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).
  • Experimental: Lemzoparlimab + Azacitidine in MDS (Escalation)
    Lemzoparlimab (TJ011133) co-administered with azacitidine in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).
  • Experimental: Lemzoparlimab + Azacitidine + Venetoclax in AML (Expansion)
    Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in expansion cohort in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.
  • Experimental: Lemzoparlimab + Azacitidine + Venetoclax in MDS (Expansion)
    Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in expansion cohort in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).
  • Experimental: Lemzoparlimab Monotherapy in AML (Japan Only Escalation)
    Lemzoparlimab (TJ011133) administered in escalated doses in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.
  • Experimental: Lemzoparlimab Monotherapy in MDS (Japan Only Escalation)
    Lemzoparlimab (TJ011133) administered in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).

Primary Outcome Measure

Dose Limiting Toxicities (DLTs) of Lemzoparlimab (TJ011133) When Co-administered With Venetoclax and Azacitidine in Participants With Treatment-Naïve Acute Myeloid Leukemia (AML) Ineligible for Standard Induction Therapy [ Time Frame: Up to 30 days after first dose of study drug ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham - Main /ID# 227071BirminghamAlabama35233-
Norton Cancer Institute - St Matthews /ID# 228378LouisvilleKentucky40207-
Beth Israel Deaconess Medical Center /ID# 231083BostonMassachusetts02215-5400-
Massachusetts General Hospital /ID# 227273BostonMassachusetts02114-
University of Michigan /ID# 227030Ann ArborMichigan48109-
University of Pennsylvania /ID# 227024PhiladelphiaPennsylvania19104-
UPMC Hillman Cancer Ctr /ID# 228048PittsburghPennsylvania15232-
MD Anderson Cancer Center at Texas Medical Center /ID# 227019HoustonTexas77030-4000-
University of Virginia Health /ID# 227363CharlottesvilleVirginia22908-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham - Main· Birmingham, ALNorton Cancer Institute - St Matthews· Louisville, KYBeth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MAUniversity of Michigan· Ann Arbor, MIUniversity of Pennsylvania· Philadelphia, PA

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