A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination with Azacitidine versus Physician's Choice of Venetoclax in Combination with Azacitidine or Intensive Chemotherapy in Previously Untreated Patients with TP53 Mutant Acute Myeloid Leukemia
Sponsor: |
Gilead Sciences |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAU1875 |
U.S. Govt. ID: |
NCT04778397 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
You are being asked to participate in this study because you have been diagnosed with a blood cancer called Acute Myeloid Leukemia (AML) with or suspected to have a specific gene mutation (TP53 mutation) for which you have not received any prior AML treatment. Tumor protein p53 (TP53) is a gene that codes for a tumor suppressor protein, which is normally important for ensuring that cells don't become cancerous. The purpose of this study is to compare the effects of the experimental group magrolimab in combination with azacitidine, to the control groups venetoclax in combination with azacitidine, or 7+3 regimen (which includes the following drugs daunorubin, idarubicin and cytarabine), to find out which is better for treating patients with AML who have mutations in the TP53 gene. Other purposes of this study include determining the quantity of magrolimab in the blood, aspects of your disease management (for example, if you can have less frequent blood transfusions), your quality of life, and the side effects these drugs have on the body.
This study is closed
Investigator
Joseph Jurcic, MD
Have you been diagnosed with Acute Myeloid Leukemia (AML)? |
Yes |
No |