This phase 3 trial aims to determine the effectiveness of Iomab-B before an hematopoietic stem cell transplantation compared to conventional treatment. The outcome to be measured is remission (no disease) and survival.
The details
Acute myeloid leukemia is a type of bone marrow cancer. Iomab-B is a drug in development for treating acute myeloid leukemia. It targets CD45, a protein present on white blood cells. When attached to the cancer cell, it delivers radiation directly into the cell.
This study will examine the effectiveness of Iomab-B in combination with Fludarabine (Fludara, a chemotherapy drug) and total body irradiation with stem cell transplantation in patients with relapsed or refractory (not responding to treatment) acute myeloid leukemia. The main outcomes will be measured by the number of patients who experience complete remission, and overall survival.
Who are they looking for?
This study is recruiting 150 participants with active, relapsed or refractory acute myeloid leukemia. The leukemia cells should have CD45 expression. The levels of circulating blasts should be less than 10,000/mm3. Participants should have adequate liver function and kidney function. Participants should not be pregnant and should be using contraception.
Participants should not have previously received radiation to maximal tolerated levels. Participants should not have leukemia that has spread to the nervous system. Participants should not have significant heart disease, HIV, hepatitis, or active infection.
How will it work
Participants will be randomly assigned to one of 2 treatment groups. Participants in the first treatment group will receive Iomab-B with fludarabine. They will then receive total body irradiation, and hematopoietic stem cell transplant. They will also receive cyclosporine (Sandimmune) or tacrolimus (Prograf) which are drugs used to suppress the immune system during the transplant. Participants in the second treatment group will receive conventional care which is chemotherapy.
Participants will all be followed-up for 1 year, to see if treatment is effective.
