A Phase I/II Study of Vadastuximab Talirine Given Before or After Stem Cell Transplantation in Patients with Recurrent or Persistent Acute Myeloid Leukemia (AML)

Full Title

SGN33A-003: A Phase 1/2 Study of Vadastuximab Talirine Administered in Sequence with Allogeneic Hematopoietic Stem Cell Transplant in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

Purpose

The purpose of this study is to find the highest dose of the investigational drug vadastuximab talirine that can be given in patients with recurrent or persistent acute myeloid leukemia (AML) when given before or after allogeneic stem cell transplantation (healthy stem cells give by a donor). Vadastuximab talirine may enhance the success of the procedure by reducing the number of AML cells before a transplant; giving the drug after transplantation could reduce the risk of relapse by killing any residual AML cells.

Vadastuximab talirine is called an "antibody-drug conjugate." It contains three parts: an antibody, an active chemotherapy drug, and a "linker" that connects the antibody to the anticancer drug. The antibody portion attaches to a protein on AML cells called CD33; once inside the cancer cell, the active drug can damage the cell. Vadastuximab talirine is given intravenously (by vein).

Part A of this study will include patients with AML who have not yet had a transplant and will receive vadastuximab talirine before transplantation. Part B is for patients who already had a transplant for AML and will therefore receive vadastuximab talirine post-transplantation.

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 before transplantation, or must have already had a stem cell transplant for recurrent or persistent AML.
  • For patients who had a stem cell transplant, the study treatment must begin at least 60 days but no more than 100 days after the transplant.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 to 75.

For more information about this study and to inquire about eligibility, please contact Dr. Sergio Giralt at 212-639-6009.

Protocol

16-062

Phase

I/II

Investigator

Locations