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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pivekimab Sunirine: Intravenous
Venetoclax: Orally
Azacitidine: Intravenous Or Subcutaneous
Matching Placebo for PVEK: Intravenous
Study summary
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.
Eligibility
Primary outcome measure(s)
- Phase 2: Complete remission (CR) — Up to Approximately 71 Months
CR per modified 2022 European LeukemiaNet (ELN) response criteria in AML - Phase 3: Complete remission (CR) — Up to Approximately 71 Months
CR per modified 2022 European LeukemiaNet (ELN) response criteria in AML - Phase 3: Overall Survival (OS) — Up to Approximately 71 Months
The time (in number of days) from randomization to death due to any cause. - Number of Participants with Adverse Events (AEs) — Up to approximately 71 months
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Trial sites (38)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope National Medical Center /ID# 279568 | Duarte | California | Recruiting |
| Moffitt Cancer Center /ID# 279192 | Tampa | Florida | Recruiting |
| Winship Cancer Institute of Emory University /ID# 279006 | Atlanta | Georgia | Recruiting |
| Washington University /ID# 280295 | St Louis | Missouri | Recruiting |
| Montefiore Medical Center - Moses Campus /ID# 279399 | The Bronx | New York | Recruiting |
| The University of Texas MD Anderson Cancer Center /ID# 279402 | Houston | Texas | Recruiting |
| Universitaetsklinikum St. Poelten /ID# 278835 | Sankt Pölten | Lower Austria | Recruiting |
| Hanusch-Krankenhaus /ID# 279467 | Vienna | State of Vienna | Recruiting |
| Medizinische Universitaet Graz /ID# 278830 | Graz | Styria | Recruiting |
| Ordensklinikum Linz Elisabethinen /ID# 278824 | Linz | Upper Austria | Recruiting |
| Medizinische Universitaet Wien /ID# 278825 | Vienna | Austria | Recruiting |
| Chu de Nice-Hopital Larchet Ii /Id# 278998 | Nice | Alpes-Maritimes | Recruiting |
| Institut Paoli-Calmettes /ID# 279015 | Marseille | Bouches-du-Rhone | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux /ID# 279001 | Pessac | New Aquitaine | Recruiting |
| Centre Hospitalier Universitaire D'Angers /ID# 280390 | Angers | Pays de la Loire Region | Recruiting |
| CHU Amiens-Picardie Site Sud /ID# 280716 | Amiens | Somme | Recruiting |
| Hopital Saint-Louis /ID# 279032 | Paris | France | Recruiting |
| Rabin Medical Center /ID# 278714 | Petah Tikva | Central District | Recruiting |
| Tel Aviv Sourasky Medical Center /ID# 278717 | Tel Aviv | Tel Aviv | 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 |
| Seoul National University Bundang Hospital /ID# 279634 | Seongnam-si | Gyeonggido | Recruiting |
| Seoul National University Hospital /ID# 279396 | Seoul | Seoul Teugbyeolsi | Recruiting |
| Yonsei University Health System - Severance Hospital /ID# 279933 | Seoul | Seoul Teugbyeolsi | Recruiting |
| Asan Medical Center /ID# 279395 | Seoul | Seoul Teugbyeolsi | Recruiting |
| Samsung Medical Center /ID# 279397 | Seoul | Seoul Teugbyeolsi | Recruiting |
| Hospital Universitario Puerta De Hierro /ID# 279660 | Majadahonda | Madrid | Recruiting |
| Clinica Universidad de Navarra - Pamplona /ID# 279516 | Pamplona | Navarre | Recruiting |
| Hospital Universitario Virgen del Rocio /ID# 279471 | Seville | Sevilla | Recruiting |
| Hospital General Universitario Gregorio Maranon /ID# 279479 | Madrid | Spain | Recruiting |
| Md Anderson Cancer Center /ID# 279480 | Madrid | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia /ID# 279635 | Valencia | Spain | Recruiting |
| China Medical University Hospital /ID# 279261 | Taichung | Taiwan | Recruiting |
| Taichung Veterans General Hospital /ID# 279296 | Taichung | Taiwan | Recruiting |
| National Taiwan University Hospital /ID# 279289 | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital /ID# 281480 | Taipei | Taiwan | Recruiting |
| Linkou Chang Gung Memorial Hospital /ID# 279294 | Taoyuan City | Taiwan | Recruiting |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07581002 on ClinicalTrials.gov ↗ ← All trials in Israel