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

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with Acute Lymphoblastic Leukemia (ALL) that is either relapsed (responded to treatment, but the cancer came back) or refractory (did not respond to treatment).

The purpose of the study is to determine if the experimental drug inotuzumab ozogamicin is a more effective treatment when compared to some standard chemotherapy regimens used in treating ALL.

Inotuzumab ozogamicin is designed to kill cancerous cells and reduce the risk of the cancer coming back. It is an antibody that targets a protein on malignant cells called CD22. The antibody is attached to a toxin that can enter and kill the cancerous cells.

 Study participants will be randomly assigned to one of two treatment arms:

  • Arm A: participants will receive inotuzumab ozogamicin via infusion
  • Arm B: participants will receive standard of care chemotherapy (either HIDAC, FLAG or cytarabine with mitoxantrone) selected by the study physician

Depending on the arm to which they are assigned and response to treatment, participants will receive a minimum of 1 to a maximum of 6 cycles of therapy. Treatment cycles will have different lengths according to the treatment received (from 15 to 18 days).

After completing treatment, participants will be followed for up to 2 years from study entry to monitor the length of response to treatment. 

Disease Status and/or Stage

Relapsed/Refractory Acute Lymphoblastic Leukemia



Key Eligibility

  • Men and women age 18 and older
  • Relapsed or refractory CD22-positive Acute Lymphoblastic Leukemia (ALL)
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Ellen Ritchie, MD


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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