A Phase III Study of Inotuzumab Ozogamicin versus Standard Therapy in Patients with Persistent or Recurrent CD22-Positive Acute Lymphoblastic Leukemia

Protocol
12-262
Full Title
An Open-label, Randomized Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigator's Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL)
Phase
III
Disease Status
Relapsed/Refractory
Purpose

The purpose of this study is to compare the side effects and effectiveness of treatment with the investigational drug inotuzumab ozogamicin versus conventional therapy in adults with acute lymphoblastic leukemia (ALL) that has persisted or returned despite therapy.

Inotuzumab ozogamicin is an antibody that targets a protein on ALL cells called CD22. The antibody is attached to a toxin called calicheamicin that can enter and kill ALL cells. Half of the patients in this study will be randomly assigned to receive inotuzumab, and the other half will receive one of three standard treatment regimens (chosen by their doctors).

Eligibility

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

  • Patients must have CD22-positive ALL that persisted or returned despite prior therapy.
  • Patients with Philadelphia chromosome-positive ALL should have received at least one regimen that included a tyrosine kinase inhibitor.
  • Patients should have recovered from the acute side effects of prior therapies before entering the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jae Park at 212-639-4048.

Disease(s)
Leukemia: Acute Lymphoblastic Leukemia
Locations
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