About this trial
This study looks at how well BP1001 works with venetoclax and decitabine for patients with acute myeloid leukemia (AML) who cannot have more intense chemotherapy. Researchers want to see if this combination helps more patients reach complete remission than venetoclax and decitabine alone. The aim is to find new treatments for patients with AML, especially those who have not responded to other drugs.
The trial's ID number is NCT02781883. It is a Phase 2 trial, which means it is looking at how well the treatment works and how safe it is. The trial hopes to include about 108 participants.
Who can join
Adults aged 18 and older can join this trial. It is open to all genders. Participants must have a specific type of AML and be unable or unwilling to receive intensive chemotherapy. The trial team will confirm who is eligible to participate.
Condition
Acute Myeloid Leukemia (AML)
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will receive treatment in one of three groups. One group will include untreated AML patients who will get BP1001 along with venetoclax and decitabine. The second group will involve patients with relapsed or refractory AML receiving the same combination. The third group will consist of patients who cannot tolerate venetoclax, who will get BP1001 and decitabine. All treatments are experimental, and participants will not be randomly assigned to groups.
Where
This trial is running at 9 locations in the United States. 6 of them are currently recruiting.
Georgia Cancer Center at Augusta University
Augusta, Georgia
Laura & Isaac Pe lmutter Cancer Center at NYU Langone Health
New York, New York
UCLA Medical Center
Los Angeles, California
University of Kansas Cancer Center
Fairway, Kansas
University of Texas M.D. Anderson Cancer Center
Houston, Texas
Weill Cornell Medical College - New York - Presbyterian Hospital
New York, New York
Baylor Scott & White Research Institute
Temple, Texas
New Jersey Hematology Oncology Associates
Brick, New Jersey
The first 8 of 9 sites are listed here. The registry record has the full list.