Purpose of this Study
In this study, people will be placed into treatment groups by a computer. They will be assigned by chance to receive either the usual treatment or a treatment that includes a study medicine called venetoclax. The usual treatment includes cancer medicines called gemtuzumab ozogamicin, cytarabine, and daunorubicin. The study treatment includes venetoclax along with cytarabine and daunorubicin.
Researchers want to compare these treatment options to see which works better and how safe they are for people with this type of leukemia.
Who Can Participate?
Eligibility
People can join this study if they are between 18 and 59 years old and have a type of blood cancer called acute myeloid leukemia with certain genetic changes. They cannot have received previous treatment for acute myeloid leukemia or a related blood condition called myelodysplastic syndrome. Participants must be healthy enough to do most daily activities, even if they need some help. They cannot be pregnant or breastfeeding. Doctors will also review other health conditions to make sure the study is safe for them.
Age Range
18-59
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is being done to find out if a new treatment plan works better than the usual treatment for a type of blood cancer called core binding factor acute myeloid leukemia. Researchers will compare the usual treatment to a treatment that includes a medicine called venetoclax.
The goal is to see which treatment helps more people reach a complete remission, meaning no signs of active leukemia can be found, and whether very small amounts of leukemia are also gone after the first phase of treatment. This information may help doctors choose the best treatment for people with this type of leukemia in the future.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
MM1YA-A04: Phase II Study of Cytarabine + Daunorubicin (7+3) + Gemtuzumab Ozogamicin vs. Cytarabine + Daunorubicin (7+3) + Venetoclax for the Treatment of Newly Diagnosed Core Binding Factor Acute Myeloid Leukemia (CBF-AML) in Younger Adults: A MyeloMATCH Substudy ( NCT:06917911)
Principal Investigator
Harry
Erba
Protocol Number
PRO00120488
NCT ID
NCT06917911
Phase
II
Enrollment Status
Pending Open to Enrollment