A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) (NCT07581002)
A Randomized Phase 2/3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination With Venetoclax and Azacitidine in Adult Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive Chemotherapy
🩺 Plain-English Summary (8th-Grade Level)
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 injection under your skin (subcutaneous) or as an infusion into the vein (intravenous) (depending on country where patient enrolls), and VEN is a tablet given by mouth. The total study duration is approximately 71 months. 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.
Who can join: Review the eligibility criteria below.
Location: City of Hope National Medical Center /ID# 279568 — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- City of Hope National Medical Center /ID# 279568 — Duarte, California
- Moffitt Cancer Center /ID# 279192 — Tampa, Florida
- Montefiore Medical Center - Moses Campus /ID# 279399 — The Bronx, New York
- Universitaetsklinikum St. Poelten /ID# 278835 — Sankt Pölten, Lower Austria
- Medizinische Universitaet Graz /ID# 278830 — Graz, Styria
- Medizinische Universitaet Wien /ID# 278825 — Vienna,
- Centre Hospitalier Universitaire D'Angers /ID# 280390 — Angers, Pays de la Loire Region
- Rabin Medical Center /ID# 278714 — Petah Tikva, Central District
- Tel Aviv Sourasky Medical Center /ID# 278717 — Tel Aviv, Tel Aviv
- Rambam Health Care Campus- Haifa /ID# 278719 — Haifa,
- Shaare Zedek Medical Center /ID# 278712 — Jerusalem,
- Hadassah Medical Center-Hebrew University /ID# 278866 — Jerusalem,
- Asan Medical Center /ID# 279395 — Seoul, Seoul Teugbyeolsi
- Samsung Medical Center /ID# 279397 — Seoul, Seoul Teugbyeolsi
- Hospital Universitario Puerta De Hierro /ID# 279660 — Majadahonda, Madrid
- China Medical University Hospital /ID# 279261 — Taichung,
- Taichung Veterans General Hospital /ID# 279296 — Taichung,
- Linkou Chang Gung Memorial Hospital /ID# 279294 — Taoyuan City,
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Acute Myeloid Leukemia
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- Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT — Tampa, Florida
- Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy — Little Rock, Arkansas
- Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia — Burbank, California
- A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies — Duarte, California
- A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia — Madera, California
Explore by condition: All Acute Myeloid Leukemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.