Inotuzumab Ozogamicin for Children with MRD Positive CD22+ Lymphoblastic Leukemia

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03913559

Provider View

This study is testing a drug called inotuzumab ozogamicin (Besponsa) in children with a type of leukemia that still shows signs of disease after initial treatment. The goal is to see if this drug can help eliminate the remaining cancer cells.

Patient Parameters

Program Overview

This trial is a Phase II study involving multiple centers to test inotuzumab ozogamicin in children with a specific type of leukemia called MRD positive CD22+ B-lymphoblastic leukemia (B-ALL). Some children with newly diagnosed leukemia still have low levels of cancer cells even after treatment. Others may see these levels rise again during or after treatment. This study aims to find new ways to completely eliminate these cancer cells in high-risk patients. Inotuzumab ozogamicin is a targeted therapy that attaches to a protein called CD22, found in most B-cell ALL cases, and delivers a powerful anti-cancer drug directly to the cancer cells. It has shown promising results in adults with similar types of leukemia.

Description

The drug inotuzumab ozogamicin will be given through an IV on days 1, 8, and 15 of each 28-day cycle. If the treatment is working and there are no major side effects, patients may receive up to five more cycles. After finishing the treatment, patients will be monitored for one year to check their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be under 22 years old.
  • Must have B-ALL with low levels of cancer cells (MRD) between 0.1% and 4.99% after at least two previous treatments, relapse, or after a stem cell transplant.
  • Cancer cells must show the CD22 marker.
  • Must have a performance score of 50% or higher, indicating they are able to carry out daily activities with some help.
  • Must have recovered from any side effects of previous cancer treatments.
  • Must have waited a certain amount of time after previous treatments, such as 14 days after chemotherapy or 42 days after CAR-T cell therapy.
  • Must have had no more than one previous bone marrow transplant and be off immune suppression for at least two weeks if applicable.
  • Must have adequate kidney, liver, and heart function as determined by specific medical tests.

Exclusion Criteria

  • History of a liver condition called sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD).
  • Currently receiving other chemotherapy or targeted cancer treatments, except for certain types of brain treatments.
  • Have severe or uncontrolled medical conditions that could affect participation in the study.
  • Have known HIV or active hepatitis B or C infections.
  • Are pregnant or breastfeeding. Female participants must have a negative pregnancy test before starting treatment.
  • Participants of reproductive age must agree to use contraception during the study and for at least 30 days after the last dose.
  • Unable or unwilling to provide informed consent.

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