Purpose of this Study
We are doing this study to compare the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib. We want to find out if adding gilteritinib to the usual treatment is beneficial for people with acute myeloid leukemia (AML).
Who Can Participate?
Eligibility
Adults ages 60+ who:<ul>
<li>Are diagnosed with AML</li>
<li>Have not received previous treatment for AML with some exceptions (exceptions = hydroxyurea, all-trans retinoic acid, leukapheresis, and cytarabine-based emergency therapy)</li>
<li>Have an FLT3-ITD or D835 mutation</li></ul>
Patients who are younger than 60 years old can be considered if their treating physician believes that an azanucleoside-based therapy rather than intensive, cytarabine-based treatment is more likely to be favorable for them.
For more information about this study, contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.<a>
<li>Are diagnosed with AML</li>
<li>Have not received previous treatment for AML with some exceptions (exceptions = hydroxyurea, all-trans retinoic acid, leukapheresis, and cytarabine-based emergency therapy)</li>
<li>Have an FLT3-ITD or D835 mutation</li></ul>
Patients who are younger than 60 years old can be considered if their treating physician believes that an azanucleoside-based therapy rather than intensive, cytarabine-based treatment is more likely to be favorable for them.
For more information about this study, contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.<a>
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will get a random assignment (like drawing straws) to 1 of 3 groups:<ul>
<li><strong>Group One:</strong> If you are in this group, you will get the drugs azacitidine and venetoclax. You will receive azacitidine by injection into a vein in your arm or subcutaneously (under the skin). You will get venetoclax as tablets that you take by mouth. You will take these drugs for defined time periods called "cycles" and be assessed at the end of each cycle. Each cycle lasts 28 days. There will be a maximum of 24 cycles.</li>
<li><strong>Group Two:</strong> If you are in this group, you will get the drugs azacitidine, venetoclax, and gilteritinib. You will receive azacitidine by injection into a vein in your arm or subcutaneously (under the skin). You will get venetoclax and gilteritinib as tablets that you take by mouth. Each cycle lasts 28 days. There will be a maximum of 24 cycles.</li>
<li><strong>Group Three:</strong> If you are in this group, you will get the drugs azacitidine, venetoclax, and gilteritinib. You will receive azacitidine by injection into a vein in your arm or subcutaneously (under the skin). You will get venetoclax and gilteritinib as tablets that you take by mouth. Each cycle lasts 28 days. There will be a maximum of 24 cycles.</li></ul>
<li><strong>Group One:</strong> If you are in this group, you will get the drugs azacitidine and venetoclax. You will receive azacitidine by injection into a vein in your arm or subcutaneously (under the skin). You will get venetoclax as tablets that you take by mouth. You will take these drugs for defined time periods called "cycles" and be assessed at the end of each cycle. Each cycle lasts 28 days. There will be a maximum of 24 cycles.</li>
<li><strong>Group Two:</strong> If you are in this group, you will get the drugs azacitidine, venetoclax, and gilteritinib. You will receive azacitidine by injection into a vein in your arm or subcutaneously (under the skin). You will get venetoclax and gilteritinib as tablets that you take by mouth. Each cycle lasts 28 days. There will be a maximum of 24 cycles.</li>
<li><strong>Group Three:</strong> If you are in this group, you will get the drugs azacitidine, venetoclax, and gilteritinib. You will receive azacitidine by injection into a vein in your arm or subcutaneously (under the skin). You will get venetoclax and gilteritinib as tablets that you take by mouth. Each cycle lasts 28 days. There will be a maximum of 24 cycles.</li></ul>
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
MyeloMATCH MM1OA-EA02, A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial (NCT06317649)
Principal Investigator
Harry
Erba
Protocol Number
PRO00116258
NCT ID
NCT06317649
Phase
II
Enrollment Status
Pending Open to Enrollment