Rajneesh Nath, MD, discusses the design of the SIERRA trial (NCT02665065), which evaluated 131 I apamistamab (Iomab-B) in elderly patients with relapsed/refractory acute myeloid leukemia.
Rajneesh Nath, MD, the section chief of Cellular Therapy/Stem Cell Transplant and Leukemia at Banner MD Anderson Cancer Center, discusses the design of the SIERRA trial (NCT02665065), which evaluated 133 I apamistamab (Iomab-B) in elderly patients with relapsed/refractory acute myeloid leukemia (AML).
According to Nath, the trial enrolled patients over the age of 55 with relapsed/refractory AML, with a fully matched donor. Patients were randomized into either the experimental arm or the standard of care arm. If patients were randomized into the experimental arm, they received Iomab-B after transplant, even if the patient had active disease. The primary end point of the trial is duration of remission.
If the patient is randomized to receive the standard of care, they would receive the chemotherapy of the oncologist’s choosing. If remission is achieved after receiving chemotherapy, they can go onto stem cell transplant. If remission is not achieved, patients in the control can be crossed over to the Iomab-B arm.
0:08 | This was an interim analysis of the SIERRA trial of Iomab-B in elderly relapsed/refractory patients with AML. The way that trial worked was if you are over the age of 55, and have a relapsed or refractory acute myelogenous leukemia, and you have a fully matched donor. These patients are randomized one to one either to the Iomab-B, which is the experimental arm or the standard of care arm. If they go to the Iomab-B, they get a transplant, even though they have an active disease at the time. If they go into remission, we look at what is the duration of remission, and the primary end point of the trial is 6-month duration of remission.
1:00 |In that case that they are randomized to the standard of care, they can get whatever chemotherapy of the choosing of the treating oncologist, if they go into remission after receiving that chemotherapy, they can get a standard stem cell transplant or the treating physicians oncologist team, or if they do not go into remission, they can be crossed over to the Iomab-B arm and receive the transplant in that arm. What we looked at was the toxicity in these 2 groups of patients.