EA9181 (Acute Lymphoblastic Leukemia)
What is the Purpose of this Study?
If you choose to join this study, you will:
- Be assigned 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)
- Be assigned 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)
What is the Condition Being Studied?
Newly Diagnosed (BCR-ABL-Positive) Acute Lymphoblastic Leukemia
Who Can Participate in this Study?
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
For more information about who can join this study, please contact the study team at 919-684-8964
Age Group
Adults
Participating Institutions
What is Involved?
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.
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
Protocol Number
IRB:
PRO00108100
NCT:
NCT04530565
ClinicalTrials.gov
View on ClinicalTrials.gov