A Phase I Study of Inotuzumab Ozogamicin in People with Acute Lymphocytic Leukemia Who Have Received a Stem Cell Transplant

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Full Title

Inotuzumab Ozogamicin Post-Transplant for Acute Lymphocytic Leukemia

Purpose

Inotuzumab ozogamicin is a drug used to treat acute lymphocytic leukemia (ALL) that has relapsed. Doctors wonder if inotuzumab ozogamicin can be used to prevent the return of ALL after stem cell transplantation. In this study, researchers will find the highest dose of inotuzumab ozogamicin that can be given safely in people who had a stem cell transplant for ALL and have a high risk of cancer recurrence.

Inotuzumab ozogamicin is an antibody attached to a chemotherapy drug. The antibody attaches to a protein on ALL cells called CD22. Once attached, the chemotherapy enters the cancer cell, causing the cancer cell to die. Inotuzumab ozogamicin is given intravenously (by vein).

Eligibility

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

  • Patients must have received a stem cell transplant for CD22-positive ALL 40-100 days before entering the study.
  • Patients must have a high risk of ALL recurrence.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients ages 16-75.

For more information about this study and to inquire about eligibility, please contact Dr. Christina Cho at 212-639-7523.

Protocol

19-228

Phase

I/II

Investigator

Co-Investigators