Promising leukemia drug falls short in kids trial

NCT ID NCT03913559

Terminated Disease control Sponsor: St. Jude Children's Research Hospital Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested inotuzumab ozogamicin (Besponsa) in children with B-cell acute lymphoblastic leukemia who had low levels of remaining cancer cells (MRD) despite treatment. The drug targets CD22, a protein on leukemia cells, and delivers a potent toxin. Only 5 children were enrolled before the study was terminated early, limiting what can be learned about its effectiveness and safety.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Inotuzumab ozogamicin (Besponsa)
What this could lead to: If successful, this could offer a new option to clear remaining leukemia cells in children with high-risk B-ALL, potentially improving outcomes before or after transplant.
What could go wrong: The trial was terminated early with only 5 participants, so results are very limited. The drug carries a risk of liver damage and veno-occlusive disease, especially after transplant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia Burkitt lymphoma precursor B-cell acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE LYMPHOBLASTIC LEUKEMIA

Contacts and locations

Locations

Rady Children's Hospital San Diego

San Diego, California, 92123, United States
St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

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