Brentuximab Vedotin + Re-induction Chemotherapy for AML
Status:
Completed
Trial end date:
2019-05-01
Target enrollment:
Participant gender:
Summary
This research study is a Phase I clinical trial. Phase I trials test the safety of an
investigational drug or combination of drugs. These trials also try to define the appropriate
dose of the investigational drug to use for further studies. "Investigational" means that the
combination of drugs is still being studied and that research doctors are trying to find out
more about it. As part of this research study, patients will be administered brentuximab
vedotin in combination with a conventional re-induction chemotherapy regimen called MEC,
which consists of the chemotherapy drugs mitoxantrone, etoposide, and cytarabine. Brentuximab
vedotin has not been approved by the FDA for the patient's cancer. However, brentuximab
targets a protein on tumors called CD30, and it is approved for other cancers which express
CD30, and these include Hodgkin lymphoma. This means that the FDA has not approved giving
brentuximab in conjunction with MEC for use in people, including people with this type of
malignancy, acute myeloid leukemia (AML).
Mitoxantrone, etoposide and cytarabine are chemotherapy agents that are commonly used to
treat individuals with relapsed AML. Brentuximab is an antibody-drug conjugate (ADC), which
is the combination of an antibody (a protein that binds to cells) and a drug. Brentuximab
vedotin works by using the antibody portion to enter into CD30-positive cells and then
releasing the drug portion, which attempts to destroy the cell. Brentuximab vedotin has been
used in laboratory and other research studies and information from those studies suggest that
brentuximab vedotin may slow down the spread of cancers which express CD30. Some AML cell
express CD30, so investigators hope that brentuximab vedotin will help with this type of AML.
The primary purpose of this research study is to determine the highest dose that Brentuximab
vedotin can safely be given with MEC without severe or unmanageable side effects. The dose
identified in this study will be used in future research studies.