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NCT04912063 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT04912063: Clinical Trial Phase 1 study, sponsored by AbbVie.
NCT04912063 is a Phase 1 study that was terminated before completion, run by AbbVie. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04912063, a Phase 1 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications and occurring during the first 4 weeks after administration of the first dose and that meets additional criteria as described in the protocol.
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Lemzoparlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-06-25 |
| Est. Completion | 2023-05-09 |
| Phase | Phase 1 |
Why NCT04912063 stopped before completion
NCT04912063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT04912063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04912063 about?
NCT04912063 is a clinical study titled "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". 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 bod...
What is the current status of trial NCT04912063?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2021-06-25. Estimated completion is 2023-05-09.
What interventions are being tested in trial NCT04912063?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Lemzoparlimab (DRUG).
Who is sponsoring clinical trial NCT04912063?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04912063's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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