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Study of Inotuzumab Ozogamicin and drug combination in adult patients with B-cell Acute Lymphoblastic Leukemia who have minimal residual disease before stem cell transplantation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on adults with B-cell Acute Lymphoblastic Leukemia, a rare type of blood cancer that affects cells that develop into white blood cells. The study specifically looks at patients who have minimal residual disease (small numbers of cancer cells that remain after treatment) before receiving a hematopoietic stem cell transplantation (a procedure that replaces blood-forming cells).

The main treatment being studied is Inotuzumab Ozogamicin (also known as Besponsa), which will be given through an intravenous infusion. Additional medications that may be used in the treatment include Cyclophosphamide, Methotrexate, Prednisone, Ponatinib, Vincristine, and Mercaptopurine. The purpose of the study is to determine how well Inotuzumab Ozogamicin works in eliminating remaining cancer cells in patients.

The treatment period may last up to two years, during which patients will receive the study medication through regular infusions. Throughout the study, doctors will monitor the presence of cancer cells and track how patients respond to the treatment. They will also watch for any side effects that may occur during or after the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your bone marrow will be examined to confirm that blast cells are less than 5% and that you are in complete remission

    Laboratory tests will check your liver function through bilirubin, ALT, and AST levels

    Your pancreatic function will be evaluated through lipase and amylase tests

  2. Step 2

    Treatment course 1

    You will receive Inotuzumab ozogamicin (Besponsa) through intravenous infusion

    Your response to treatment will be monitored through blood tests and bone marrow examination

    Your minimal residual disease (MRD) levels will be measured after the first course

  3. Step 3

    Treatment course 2

    A second course of Inotuzumab ozogamicin may be administered if needed

    Your MRD levels will be measured again after the second course

    Regular monitoring of liver and pancreatic function will continue

  4. Step 4

    Additional medications

    You may receive additional medications as part of your treatment:

    Cyclophosphamide - given through intravenous infusion

    Methotrexate - given through intravenous infusion

    Prednisone - taken by mouth

    Ponatinib - taken by mouth

    Vincristine - given through intravenous infusion

    Mercaptopurine - taken by mouth

  5. Step 5

    Follow-up period

    Your health status will be monitored for up to 2 years after treatment

    Regular checks will be performed to detect any side effects or complications

    Your disease status will be evaluated through blood tests and examinations

Who can join the trial?

13 criteria

  • Must be 18 years or older with no upper age limit
  • Must have been diagnosed with B-cell Lymphoblastic Leukemia with more than 20% of cancer cells (blasts) in bone marrow at diagnosis
  • Must have cancer cells that are CD22 positive (a specific marker on the surface of cancer cells)
  • Must be in first or second complete remission with less than 5% cancer cells in bone marrow
  • Must have a life expectancy of more than 12 weeks
  • Must have normal liver function, specifically:
    • Normal bilirubin levels (unless due to Gilbert's syndrome)
    • Normal levels of liver enzymes (ALT and AST)
    • Must have normal pancreas function, with normal levels of lipase and amylase enzymes
    • For women who can become pregnant, must have a negative pregnancy test during screening
    • Both men and women who can have children must use effective contraception during the study and for 4 months after treatment ends
    • Women who are breastfeeding must stop during treatment and should not restart after treatment
    • Men must agree not to donate sperm during treatment and for 12 months after the last dose
    • Must provide written informed consent to participate in the study

Who cannot join the trial?

15 criteria

  • History of prior treatment with Inotuzumab ozogamicin (a type of targeted cancer therapy)
  • Active central nervous system involvement of leukemia (cancer cells present in brain or spinal cord)
  • Significant heart conditions, including:
    • Heart failure (when heart cannot pump blood effectively)
    • Recent heart attack (within past 6 months)
    • Unstable heart rhythm disorders
    • Severe liver problems or active liver disease
    • Active uncontrolled infections
    • Known HIV infection
    • Active hepatitis B or C infection
    • Pregnancy or breastfeeding
    • Unable to provide informed consent
    • Current participation in other clinical trials
    • Major surgery within 4 weeks before starting the study
    • Any condition that, in the opinion of the study doctor, would make participation unsafe
    • History of other cancers within the past 3 years (except for successfully treated skin cancer or cervical cancer in situ)
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Investigated drugs

Inotuzumab ozogamicin is a targeted cancer medication used to treat B-cell acute lymphoblastic leukemia (ALL). It works by attaching to cancer cells that have a specific protein called CD22 on their surface, and then delivers a substance that kills these cancer cells. This medication is given through an intravenous (IV) infusion and is specifically used when there are small amounts of cancer cells remaining in the body (minimal residual disease) before a stem cell transplant procedure.

What is already known about the treatment

Inotuzumab Ozogamicin – An antibody-drug conjugate administered intravenously that is used in the treatment of acute B-cell lymphoblastic leukemia (ALL) in adult patients with minimal residual disease before stem cell transplantation. This medication works by targeting CD22 protein on the surface of leukemia cells and delivering a toxic substance directly to these cancer cells, effectively destroying them while minimizing damage to healthy cells. As a targeted immunotherapy agent, it belongs to the class of antibody-drug conjugates and has shown significant effectiveness in clinical trials for patients with B-cell ALL who maintain minimal residual disease, representing an important therapeutic option in pre-transplant treatment protocols.

Investigated diseases

Acute B-cell Lymphoblastic Leukemia - A blood and bone marrow cancer that affects B-lymphocytes, a type of white blood cell. The disease develops when immature B-cells (called lymphoblasts) multiply uncontrollably in the bone marrow, preventing the production of normal blood cells. These abnormal cells quickly build up and spread to other parts of the body through the bloodstream. The condition progresses rapidly over a few weeks, affecting the body's ability to fight infections and maintain normal blood cell counts. In some cases, small numbers of cancer cells can remain in the body even after initial treatment, which is known as minimal residual disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510516-39-00Protocol codeALL2418Estimated enrolment76 patientsSponsorFondazione Gimema Franco Mandelli Onlus

sourced from the EU Clinical Trials Register and site verification

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