Purpose of this Study
We are doing this study to find out if an experimental combination of drugs is an effective treatment for ALL. The combination used in the study is blinatumomab (the study drug) + steroids and tyrosine kinase inhibitors (TKI). We want to know if this drug combination is more effective than the standard treatment of chemotherapy + steroids and TKI.
Who Can Participate?
Eligibility
Adults ages 18-75 who:
- Are diagnosed with Acute Lymphoblastic Leukemia and have a gene called BCR/ABL
- Have not received chemotherapy treatment for this type of leukemia
- Do not have serious epilepsy that needs to be treated
Age Range
18-75
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 to 1 of 2 treatment groups:
- One group will get the standard treatment of chemotherapy + steroids and TKI
- The other will get the study drug + steroids and TKI
- Have physical exams
- Have bone marrow samples taken
- Have a fluid sample taken from your spinal canal (lumbar puncture)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
EA9181: A Phase III Randomized Trial of Steroids + TKI Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-positive ALL in Adults
Principal Investigator
Harry
Erba
Protocol Number
PRO00108100
NCT ID
NCT04530565
Phase
III
Enrollment Status
Open to Enrollment