Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruitingRare disease

Testing inotuzumab ozogamicin and blinatumomab with drug combination for children with relapsed precursor B-cell acute lymphoblastic leukemia

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study is looking at Acute Lymphoblastic Leukemia that has come back after previous treatment, specifically a type called precursor B-cell leukemia. The study uses different combinations of treatments depending on how serious the disease is and how well it responds to therapy. The medications involved include inotuzumab ozogamicin, blinatumomab, methotrexate, etoposide, cytarabine, ifosfamide, vindesine sulfate, prednisolone sodium succinate, vincristine sulfate, daunorubicin hydrochloride, mitoxantrone, mercaptopurine, idarubicin hydrochloride, pegaspargase, dexamethasone phosphate, tioguanine, and cyclophosphamide. Some of these medications are given through a vein, some by mouth, and some directly into the spinal fluid area.

The purpose of this study is to find out which treatment combinations work best for children whose leukemia has returned. The study will compare different treatment approaches to see which ones help patients live longer without the disease coming back and which ones are safer with fewer side effects. For some patients, the study will test whether newer medications like inotuzumab ozogamicin or blinatumomab work better than standard chemotherapy treatments. For other patients, the study will look at whether using fewer chemotherapy courses before giving blinatumomab is just as effective as using more chemotherapy courses.

During the study, patients will receive treatment in different phases. The first phase aims to reduce the cancer cells in the body, and this is called induction therapy. After this, patients may receive additional treatment phases called consolidation therapy to help keep the cancer from coming back. Throughout treatment, doctors will check how much disease remains in the body using special tests that can detect very small amounts of cancer cells. Based on these test results and other factors, doctors will decide which specific treatment plan is best for each patient. Some patients may eventually receive a stem cell transplant as part of their treatment plan.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Induction therapy

    This is the first treatment phase after joining the study. The goal is to reduce the number of cancer cells in the body and achieve remission.

    Depending on your specific situation and the treatment arm assigned, you will receive one of several possible medication combinations. The treatment team will determine which approach is appropriate based on your disease characteristics.

    If you are in the standard risk group with bone marrow involvement, you may receive either inotuzumab ozogamicin (a targeted therapy given through a vein) or a combination that includes mitoxantrone (a chemotherapy drug given through a vein).

    Other medications that may be used during this phase include vincristine sulfate (given through a vein), dexamethasone phosphate (given by mouth or through a vein), daunorubicin hydrochloride (given through a vein), cytarabine (given through a vein or directly into the spinal fluid), methotrexate (given through a vein or directly into the spinal fluid), and pegaspargase (given through a vein).

    The specific dosages, frequency, and duration of each medication will be determined by the treatment protocol and your individual response to therapy.

    Blood tests and bone marrow examinations will be performed to assess how well the treatment is working and to measure the level of remaining disease cells, known as minimal residual disease or MRD.

  2. Step 2

    Consolidation therapy

    After induction therapy, the next phase aims to eliminate any remaining cancer cells and prevent the disease from returning.

    The type of consolidation therapy you receive depends on your risk group and how well you responded to induction treatment, particularly your MRD level.

    If you are in the standard risk group and achieved a good response (MRD less than one in ten thousand cells after induction), you may receive blinatumomab, which is a type of immunotherapy given as a continuous infusion through a vein over several weeks. This treatment may be given in up to three courses.

    If you are in the high risk group and achieved remission after induction, you may receive one course of intensive chemotherapy called HC1 followed by blinatumomab. The chemotherapy course includes medications such as cytarabine, etoposide, and other drugs given through a vein.

    If you had an isolated relapse outside the bone marrow (extramedullary relapse) and achieved remission, you will receive consolidation therapy that includes blinatumomab in the later phase of treatment.

    Other chemotherapy medications that may be used during consolidation include cyclophosphamide (given through a vein), ifosfamide (given through a vein), vindesine sulfate (given through a vein), prednisolone sodium succinate (given through a vein or by mouth), idarubicin hydrochloride (given through a vein), mercaptopurine (given by mouth), and tioguanine (given by mouth).

    Medications may also be given directly into the spinal fluid to prevent or treat disease in the central nervous system.

    The duration of consolidation therapy varies depending on the specific treatment plan, but typically involves multiple cycles over several months.

  3. Step 3

    Stem cell transplantation preparation (if applicable)

    Depending on your risk category and response to treatment, you may be prepared for a stem cell transplant, also known as allogeneic hematopoietic stem cell transplantation or allo-HSCT.

    This procedure involves receiving high doses of chemotherapy to eliminate remaining cancer cells, followed by an infusion of healthy stem cells from a donor to rebuild the blood and immune system.

    Not all patients will require a stem cell transplant. The decision is based on factors such as your risk group, MRD levels, and overall response to therapy.

    If a transplant is planned, additional evaluations and procedures will be performed to prepare for this treatment.

  4. Step 4

    Monitoring and follow-up

    Throughout all phases of treatment, regular monitoring will be performed to assess your response to therapy and manage any side effects.

    This includes blood tests, bone marrow examinations, and imaging studies as needed.

    Side effects will be monitored and graded according to standard toxicity scales. Any serious adverse events will be documented and managed appropriately.

    The presence of CD19 positive cells and CD22 positive cells (specific markers on the surface of leukemia cells) will be checked at various time points to ensure the targeted therapies can work effectively.

    For some medications, particularly inotuzumab ozogamicin, blood samples may be collected to measure drug levels in the body and understand how the medication is processed.

    Long-term follow-up will continue after the completion of active treatment to monitor for any signs of disease recurrence and to assess overall survival and disease-free survival.

Who can join the trial?

13 criteria

  • The patient must have a confirmed diagnosis of B-cell precursor ALL (a type of blood cancer called acute lymphoblastic leukemia) that has come back for the first time after initial treatment
  • The patient must be starting treatment during the time period when the study is active
  • The patient must be at least 1 year old when first diagnosed with ALL and younger than 21 years old when joining this study
  • The patient must be enrolled at a medical center that is participating in this study
  • A written agreement to participate in the study must be provided
  • The patient cannot be participating in other clinical trials within 30 days before joining this study that would interfere with this treatment plan (except for trials related to the original ALL diagnosis)
  • For certain treatment groups: The patient must have bone marrow involvement (at least 1% cancer cells found in the soft tissue inside bones where blood cells are made)
  • For certain treatment groups: The cancer cells must be CD22 positive (more than 80% of the cancer cells have a specific protein marker called CD22 on their surface, confirmed by a laboratory test)
  • For certain treatment groups: The cancer cells must be CD19 positive (more than 10% of the cancer cells have a specific protein marker called CD19 on their surface)
  • For certain treatment groups: The patient must have no previous history of veno-occlusive disease or sinusoidal obstruction syndrome (serious conditions affecting blood vessels in the liver)
  • For certain treatment groups: After initial treatment, the patient must have M1 status or CR2 (the bone marrow has less than 5% cancer cells, indicating a good response to treatment)
  • For certain treatment groups: The level of minimal residual disease or MRD (very small amounts of cancer cells remaining after treatment that can only be detected by special tests) must be either less than or greater than a specific measurement depending on the treatment group
  • For certain treatment groups: The patient must have an extramedullary relapse (cancer that has come back outside the bone marrow) confirmed by tissue examination, with no bone marrow involvement and MRD less than 1%

Who cannot join the trial?

5 criteria

  • No specific exclusion criteria have been provided for this clinical trial
  • Please note that this study involves patients with relapsed acute lymphoblastic leukemia, which means the cancer of white blood cells has come back after previous treatment
  • The study uses specific medications including inotuzumab ozogamicin (a targeted therapy that delivers chemotherapy to cancer cells) and blinatumomab (a type of immunotherapy that helps the immune system fight cancer cells)
  • Because detailed exclusion criteria are not listed in the available information, your doctor will need to review your complete medical history to determine if you are eligible to participate
  • General factors that might prevent participation could include other serious medical conditions, previous reactions to similar treatments, or pregnancy, but these would need to be confirmed by the research team
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Inotuzumab ozogamicin

    is a targeted therapy medication that works by attaching to specific proteins found on the surface of cancer cells. Once attached, it delivers a toxic substance directly into the cancer cells to destroy them. In this trial, it is being tested to see if it can improve treatment outcomes for children with relapsed leukemia.

  • Mitoxantrone

    is a chemotherapy medication that works by interfering with the DNA inside cancer cells, which prevents them from growing and dividing. It is used as part of a treatment combination for children whose leukemia has come back after initial treatment.

  • Blinatumomab

    is a type of immunotherapy medication that helps the body's immune system fight cancer. It works by connecting immune cells to cancer cells, allowing the immune system to recognize and destroy the leukemia cells. In this trial, it is being tested at different stages of treatment to see if it can help keep the cancer from coming back.

What is already known about the treatment

  • Inotuzumab Ozogamicin

    This is a targeted cancer medication given through an intravenous infusion (directly into a vein) that is being studied in clinical trials for treating children with relapsed acute lymphoblastic leukemia, a type of blood cancer that has come back after initial treatment. The drug works by combining an antibody that specifically finds and attaches to cancer cells with a toxic substance that kills these cells once delivered inside them, acting like a guided missile that targets cancer while minimizing damage to healthy cells. It belongs to a class of medications called antibody-drug conjugates, which are designed to deliver chemotherapy directly to cancer cells. This medication is currently approved for use in adult patients with certain types of leukemia and is being tested to see if it can improve survival rates in pediatric patients when compared to standard chemotherapy regimens.

  • Blinatumomab

    This is an immunotherapy medication administered as a continuous intravenous infusion (through a vein over an extended period) that is being evaluated in this clinical trial for treating children with relapsed acute lymphoblastic leukemia who have achieved remission. The drug works by acting as a bridge between the patient's own immune system T-cells and the cancer cells, bringing them close together so the T-cells can recognize and destroy the leukemia cells more effectively. It is classified as a bispecific T-cell engager antibody, meaning it connects two different types of cells to fight cancer using the body's natural defense system. This medication is already approved for certain types of leukemia in adults and children, and this study aims to determine if it can improve long-term survival rates when used in different treatment phases for pediatric patients with relapsed disease.

Investigated diseases

Relapsed Acute Lymphoblastic Leukemia – Relapsed Acute Lymphoblastic Leukemia is a cancer of the blood and bone marrow that returns after a period of remission following initial treatment. This disease occurs when abnormal white blood cells called lymphoblasts multiply uncontrollably in the bone marrow and blood. The relapse means that leukemia cells have returned after responding to earlier therapy. These cancer cells crowd out normal blood cells, preventing the body from producing enough healthy red blood cells, white blood cells, and platelets. The disease can affect both children and adults, though it is more common in children. When the disease relapses, it may return in the bone marrow, blood, or in areas outside the bone marrow such as the central nervous system or other organs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509392-17-00Protocol codeIntReALL BCP 2020Estimated enrolment805 patientsSponsorCharite Universitaetsmedizin Berlin KöR

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.