Condition: Acute Myeloid Leukemia · Sponsor: AbbVie
Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow (the spongy tissue inside the bones) that affects white blood cells that helps to fight infections and also prevents normal blood cell production. This study will assess the adverse events and changes in the disease activity when Pivekimab Sunirine (PVEK) is given in combination with Venetoclax (VEN) and Azacitidene (AZA) in adult participants with AML ineligible to receive intensive chemotherapy. Pivekimab sunirine is a drug being evaluated in the treatment of AML.This is a Phase 2/Phase 3, study of PVEK. Phase 2 is open-label and randomized. Phase 3 is double-blind, randomized. Phase 2 and Phase 3 studies test potential new treatments in patients with a condition or disease. Open-label means that both patients and study doctors know which study treatment is given to patients in Phase 2 of the study. Double-blind means that neither the patients nor the study doctors know who is given which study treatment in Phase 3 of the study. Approximately 660 adult participants will be enrolled in 180 sites worldwide. In Phase 2 of the study, patients will be randomized to receive PVEK + VEN + AZA or standard of care treatment with VEN + AZA. In Phase 3, patients will be randomized to receive PVEK + VEN + AZA or a matching-placebo for PVEK plus VEN + AZA. PVEK is given as an infusion into the vein, AZA is given as an …
This description comes directly from the study's public registry record.
ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
Always discuss trial participation with your own doctor first.
| Mayo Clinic Hospital - Phoenix /ID# 282904 | Phoenix, Arizona, United States | Not Yet Recruiting |
| City of Hope National Medical Center /ID# 279568 | Duarte, California, United States | Recruiting |
| Mayo Clinic Hospital Jacksonville /ID# 282903 | Jacksonville, Florida, United States | Not Yet Recruiting |
| Montefiore Medical Center - Moses Campus /ID# 279399 | The Bronx, New York, United States | Recruiting |
| Tel Aviv Sourasky Medical Center /ID# 278717 | Tel Aviv, Tel Aviv, Israel | Recruiting |
| Rambam Health Care Campus- Haifa /ID# 278719 | Haifa, Israel | Recruiting |
| Shaare Zedek Medical Center /ID# 278712 | Jerusalem, Israel | Recruiting |
| Hadassah Medical Center-Hebrew University /ID# 278866 | Jerusalem, Israel | Recruiting |
| Samsung Medical Center /ID# 279397 | Seoul, Seoul Teugbyeolsi, South Korea | Recruiting |
| China Medical University Hospital /ID# 279261 | Taichung, Taiwan | Recruiting |
| Taichung Veterans General Hospital /ID# 279296 | Taichung, Taiwan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07581002