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INOMRD: Inotuzumab Ozogamicin for High-Risk B-Cell Acute Lymphoblastic Leukemia

About this study

This is a clinical trial for children and young adults with B-cell acute lymphoblastic leukemia (B-ALL) that is showing early signs of coming back (relapsing) or is not responding to treatment (refractory). Standard treatment for patients with this type of disease includes strong anti-cancer medicine called chemotherapy, followed by a bone marrow transplant, also known as a stem cell transplant.

In this study, we will test an experimental drug called inotuzumab ozogamicin (Besponsa) to find out what effect, good or bad, the drug has on patients who have relapsing or refractory B-ALL with minimal residual disease, known as MRD. This means you test positive for B-ALL, but there are no other signs of leukemia in your bone marrow or blood yet.

Inotuzumab ozogamicin is considered experimental because it is not approved by the U.S. Food and Drug Administration and is only used in research studies like this one. The drug has been approved to treat adult patients with relapsed or refractory B-cell ALL who have no other treatment options. Inotuzumab ozogamicin has only been given to a small number of children, and there is limited information about the side effects children may experience.

The drug will be administered as an IV infusion (into the vein) every 3 weeks, followed by one week of rest. This cycle may be repeated up to 6 times.

Eligibility overview

  • Younger than 22 years old
  • Diagnosis of B-ALL with minimal residual disease (MRD) between 0.1 and 4.99% after prior chemotherapy, relapse or stem cell transplant

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.


Full title:

Inotuzumab Ozogamicin for Children with MRD Positive CD22+ Acute Lymphoblastic Leukemia

Study goal:

The main goal of this study is to learn about the good and bad side effects of inotuzumab ozogamicin in children with this type of leukemia and to find out how well the drug works to get rid of the disease.


Younger than 22 years old

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.


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