A Phase III Study of Iomab-B plus Stem Cell Transplantation versus Conventional Chemotherapy in Older Patients with Recurrent or Persistent Acute Myeloid Leukemia

Full Title

Iomab-01: A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplantation versus Conventional Care in Older Subjects with Active, Relapsed or Refractory Acute Myeloid Leukemia

Purpose

With allogeneic stem cell transplantation, patients receive high doses of chemotherapy and radiation therapy to destroy their blood cells and prepare them for the transplant. This therapy is used to treat some patients with recurrent or persistent acute myeloid leukemia (AML), but it can be taxing for older adults. It is hoped that adding the investigational drug Iomab-B to stem cell transplantation may make this treatment safer for older patients and more effective than treatment with combination chemotherapy (the conventional approach for patients who cannot have a stem cell transplant).

Iomab-B is an antibody attached to a radioactive substance, and is given during the preparation for the transplant to help kill leukemia cells in the bone marrow and spleen. Patients will be randomly assigned to receive either Iomab-B plus stem cell transplantation, or conventional combination chemotherapy.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent or persistent AML that contains a protein called CD45 (the target of Iomab-B.
  • Patients must have a tissue antigen-matched related or unrelated donor who is willing to donate blood-forming bone marrow stem cells.
  • This study is for patients age 55 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Boglarka Gyurkocza at 212-639-2860.

Protocol

17-153

Phase

III

Disease Status

Relapsed or Refractory

Investigator