Blinatumomab in molecular relapse of AML with a t(8;21) translocation
Research type
Research Study
Full title
Blinatumomab in molecular relapse of acute myeloid leukaemia (AML) with a t(8;21) translocation
IRAS ID
1003598
Contact name
Richard Dillon
Contact email
Eudract number
2020-002019-23
ISRCTN Number
ISRCTN52962455
Research summary
This study will evaluate the safety and effectiveness of an antibody treatment (blinatumomab) in patients who have received treatment for a particular type of acute myeloid leukaemia (AML), but in whom molecular testing shows that the disease has not completely gone away or is starting to come back. The standard treatment for these patients is intensive chemotherapy which has severe side effects. We wish to investigate whether the antibody treatment can achieve the same results with less toxicity. Blinatumomab is very effective in this situation in a different type of leukaemia (B-cell acute lymphoblastic leukaemia, B-ALL) and is now standard treatment in the NHS and worldwide. This is the first time that blinatumomab has been tested in AML.
This is a phase 2 study and to start with will be run at one hospital. Patients who enter the study will be admitted to hospital to start the antibody treatment, which is given by continuous infusion into a vein. They will stay in hospital for three days to make sure there are no reactions and will then be allowed to go home with a portable pump, which will continue to infuse the antibody for a total of 28 days. If the treatment works, patients can have up to four cycles in total. Most patients will have a bone marrow transplant after completing the antibody treatment - this is standard procedure and not part of the trial.
REC name
Wales REC 2
REC reference
21/WA/0243
Date of REC Opinion
27 Sep 2021
REC opinion
Further Information Favourable Opinion