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INOMRD: Inotuzumab Ozogamicin for Children with High-Risk B-Cell ALL

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


Leukemia / Lymphoma

Phase I/II

Diseases Treated:

Acute lymphoblastic leukemia

Eligibility Overview:

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

    This trial is a limited multi-center, Phase II study to evaluate inotuzumab ozogamicin (Besponsa) in pediatric patients with MRD positive CD22-positive B-lymphoblastic leukemia (B-ALL).

    Some patients with newly diagnosed ALL maintain low levels of MRD, despite achieving complete remission with less than 5% blasts in the bone marrow. Others experience re-emergence of low level MRD or increasing levels of MRD on therapy or post-transplant. New approaches are needed to achieve undetectable MRD in these high-risk patients.

    Inotuzumab ozogamicin is an antibody-drug conjugate composed of a humanized IgG subtype 4 monoclonal CD22-targeted antibody linked to calicheamicin, a potent anti-tumor antibiotic. CD22 is expressed in more than 90% of patients with B-cell ALL, making it an attractive target in this patient population. Inotuzumab ozogamicin has demonstrated exceptional activity in adults with relapsed or refractory B-ALL.

    The drug will be administered intravenously on days one, eight and 15 of each 28-day cycle. Patients who do not meet the definition of treatment failure after the first cycle may receive up to five additional cycles of therapy.

    Primary Objective

    • Assess the effectiveness of inotuzumab ozogamicin in patients with MRD positive CD22+ B-ALL

    Eligibility Criteria

    Inclusion criteria include:

    • Younger than 22 years old
    • Diagnosis of B-ALL with persistent or rising MRD between 0.1 and 4.99% without extramedullary disease following at least two prior induction attempts, relapse or after hematopoietic stem cell transplant
    • Leukemia blasts demonstrating surface expression of CD22
    • Karnofsky or Lansky performance score ≥ 50%

    Exclusion Criteria include:

    • History of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD)
    • Concurrent chemotherapy or targeted anti-cancer agents, other than intrathecal therapy
    • Known HIV infection or active hepatitis B or C
    • Pregnant or breastfeeding

    Study Sites

    St. Jude Children’s Research Hospital, Memphis, Tennessee

  2. 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 and/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 three weeks, followed by one week of rest. This cycle may be repeated up to six times.

    Purpose of this clinical trial

    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.

    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
  3. INOMRD  Quick View
    Sponsors St. Jude Children’s Research Hospital and Pfizer, Inc. identifier NCT03913559
    Trial start date February 2019
    Estimated enrollment 32
    Study type Interventional
    Study phase Phase II

    B-lymphoblastic leukemia (B-ALL)

    Ages Younger than 22
    Principal investigator Sima Jeha, MD
    Study site St. Jude Children's Research Hospital
    For a consultation or to discuss INOMRD St. Jude Physician/Patient Referral Office


Sima Jeha, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

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.