Purpose of this Study
We are doing this study to compare different experimental drug regimens to the usual treatment (cytarabine and daunorubicin) for acute myeloid leukemia (AML). We want to find out which options have the best outcomes. The different drug combinations we will be testing against the usual treatment are:<ul>
<li>daunorubicin and cytarabine liposome</li>
<li>cytarabine and daunorubicin with venetoclax</li>
<li>azacitidine and venetoclax</li>
<li>daunorubicin and cytarabine liposome with venetoclax</li></ul>
<li>daunorubicin and cytarabine liposome</li>
<li>cytarabine and daunorubicin with venetoclax</li>
<li>azacitidine and venetoclax</li>
<li>daunorubicin and cytarabine liposome with venetoclax</li></ul>
Who Can Participate?
Eligibility
Adults ages 18-59 who:<ul>
<li>Are newly diagnosed with AML that is classified as high-risk (adverse) per ELN 2017 criteria</li>
<li>Have not started treatment yet for AML</li>
<li>Do not have acute promyelocytic leukemia</li>
<li>Do not have favorable or intermediate risk disease</li>
<li>Do not have any FLT3 mutations</li></ul>
For more information about this study, please contact the study team at <a href="mailto: marty.c.cauley@duke.edu"> marty.c.cauley@duke.edu.</a>
<li>Are newly diagnosed with AML that is classified as high-risk (adverse) per ELN 2017 criteria</li>
<li>Have not started treatment yet for AML</li>
<li>Do not have acute promyelocytic leukemia</li>
<li>Do not have favorable or intermediate risk disease</li>
<li>Do not have any FLT3 mutations</li></ul>
For more information about this study, please contact the study team at <a href="mailto: marty.c.cauley@duke.edu"> marty.c.cauley@duke.edu.</a>
Age Range
18-59
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 (fair, equal chance) to 1 of 5 groups:<ul>
<li>Group 1: If you are in this group, you will get the usual drugs used to treat this type of cancer (cytarabine and daunorubicin).</li>
<li>Group 2: If you are in this group, you will get the usual treatment drugs (cytarabine and daunorubicin) plus venetoclax.</li>
<li>Group 3: If you are in this group, you will get azacitidine and venetoclax.</li>
<li>Group 4: If you are in this group, you will get daunorubicin and cytarabine liposome.</li>
<li>Group 5: If you are in this group, you will get daunorubicin, cytarabine liposome, and venetoclax.</li></ul>
<li>Group 1: If you are in this group, you will get the usual drugs used to treat this type of cancer (cytarabine and daunorubicin).</li>
<li>Group 2: If you are in this group, you will get the usual treatment drugs (cytarabine and daunorubicin) plus venetoclax.</li>
<li>Group 3: If you are in this group, you will get azacitidine and venetoclax.</li>
<li>Group 4: If you are in this group, you will get daunorubicin and cytarabine liposome.</li>
<li>Group 5: If you are in this group, you will get daunorubicin, cytarabine liposome, and venetoclax.</li></ul>
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
MyeloMATCH MM1YA-S01: A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7 + 3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined by MYELOMATCH; A MYELOMATCH Clinical Trial
Principal Investigator
Harry
Erba
Protocol Number
PRO00116098
NCT ID
NCT05554406
Phase
II
Enrollment Status
Pending Open to Enrollment