Purpose of this Study
We are doing this study to find out if 2 different experimental drug combinations can improve outcomes for people who are newly diagnosed with AML. We want to compare the outcomes from the standard treatment (cytarabine + daunorubicin) to the following experimental regimens:
- Venetoclax + cytarabine + daunorubicin
- Venetoclax + azacitidine
Who Can Participate?
Eligibility
Adults ages 18-59 who:
- Are newly diagnosed with AML
- Have not received any previous treatment for AML
- Are registered to the Master Screening and Re-Assessment Protocol (myeloMATCH MSRP)
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
If you choose to join this study, you will get a random assignment (random chance) to 1 of 3 groups:
- Group 1: venetoclax + cytarabine + daunorubicin (experimental regimen); OR
- Group 2: venetoclax + azacitidine (experimental regimen); OR
- Group 3: cytarabine + daunorubicin (standard treatment)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Myelomatch MM1YA-CTG01: A MEASURABLE RESIDUAL DISEASE (MRD) FOCUSED, PHASE II STUDY OF VENETOCLAX PLUS CHEMOTHERAPY FOR NEWLY DIAGNOSED YOUNGER PATIENTS WITH INTERMEDIATE RISK ACUTE MYELOID LEUKEMIA: A TIER 1 MYELOMATCH CLINICAL TRIAL
Principal Investigator
Harry
Erba
Protocol Number
PRO00116800
NCT ID
NCT05554393
Phase
II
Enrollment Status
Open to Enrollment