A Phase II Study of Inotuzumab Ozogamicin in Children and Young Adults with Recurrent or Persistent B-Cell Acute Lymphoblastic Leukemia

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Full Title

A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL) AALL1621 (CIRB)

Purpose

Inotuzumab ozogamicin is a drug used to treat adults with B-cell acute lymphoblastic leukemia (ALL) that has come back or continued to grow despite prior therapy. In this study, researchers are evaluating its use in children and young adults with recurrent or persistent B-cell ALL.

Inotuzumab ozogamicin is an antibody attached to a chemotherapy drug. The antibody attaches to a protein on B-cell 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 B-cell ALL that came back or continued to grow despite prior treatment and is positive for CD22.
  • Patients must recover from the serious side effects of prior therapy before entering the study.
  • 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 1-21.

For more information and to inquire about eligibility for this study, please contact Dr. Kavitha Ramaswamy at 212-639-8451.

Protocol

18-269

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators