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Study on Obinutuzumab and Rituximab with Chemotherapy for Adults with Newly Diagnosed CD20-Positive Acute Lymphoblastic Leukemia

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What is this trial about?

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

This clinical trial is focused on studying a type of blood cancer called acute lymphoblastic leukemia (ALL), specifically in adults who have a newly diagnosed form of this disease that is positive for a marker known as CD20. The study is comparing two treatments: obinutuzumab and rituximab, both of which are given in combination with chemotherapy. These treatments are solutions that are administered through an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective these treatments are in helping patients achieve complete remission, which means that signs of cancer are reduced or disappear. The study will monitor patients to see if they reach a state where less than 0.1% of their bone marrow cells show signs of the disease after the initial treatment phase. This is an important measure of success in treating ALL.

Participants in the study will receive one of the two treatments and will be observed over a period of time to assess their response to the treatment. The study will also track the overall health and survival of the participants, as well as any side effects they may experience. The goal is to determine which treatment is more effective and safer for patients with this type of leukemia.

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

    Joining the study

    Participation begins after meeting the inclusion criteria, which include being 18 years or older, having newly diagnosed acute lymphoblastic leukemia (ALL) with CD20 expression on at least 20% of blasts, and providing signed written consent.

    Women with child-bearing potential must use adequate contraception.

  2. Step 2

    Induction treatment

    The initial phase involves receiving either obinutuzumab or rituximab in combination with chemotherapy.

    Both medications are administered through intravenous use.

    The goal is to achieve complete remission (CR) with minimal residual disease (MRD) level of less than 0.1% of bone marrow cells after one course.

  3. Step 3

    Consolidation treatment

    Following successful induction, consolidation treatment aims to further reduce MRD levels to less than 0.01% of bone marrow cells.

    This phase continues to use the assigned medication in combination with chemotherapy.

  4. Step 4

    Follow-up period

    A 24-month follow-up period is conducted to monitor overall complete remission rates, survival probabilities, and relapse incidences.

    The follow-up also assesses the rate of adverse events experienced during the trial.

Who can join the trial?

4 criteria

  • Must be at least 18 years old.
  • Must have been newly diagnosed with **acute lymphoblastic leukemia (ALL)**, which is a type of blood cancer, and have **CD20 expression** on at least 20% of the cancer cells. **CD20** is a protein found on the surface of some blood cells.
  • Must sign a written informed consent form, which means agreeing to participate in the study after being fully informed about it.
  • If a woman can have children, she must use adequate contraception to prevent pregnancy during the study.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer other than acute lymphoblastic leukemia (a type of blood cancer).
  • Patients who have already received treatment for their leukemia.
  • Patients who have a serious, uncontrolled medical condition that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study drugs or similar medications.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have participated in another clinical trial recently.
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Investigated drugs

  • Obinutuzumab

    is a medication used in this trial to treat adult patients with newly diagnosed CD20-positive acute lymphoblastic leukemia (ALL). It is a type of targeted therapy that works by attaching to a specific protein on the surface of cancer cells, helping the immune system to destroy these cells. The goal of using obinutuzumab in this trial is to see how effective it is in achieving complete remission in patients.

  • Rituximab

    is another medication being tested in this trial for the treatment of adult patients with newly diagnosed CD20-positive acute lymphoblastic leukemia (ALL). Like obinutuzumab, rituximab is a targeted therapy that binds to a specific protein on cancer cells, aiding the immune system in attacking and eliminating these cells. The trial aims to compare the effectiveness of rituximab with obinutuzumab in achieving complete remission in patients.

What is already known about the treatment

  • Obinutuzumab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating CD20-positive acute lymphoblastic leukemia (ALL) in adults. It is a monoclonal antibody that targets the CD20 protein on the surface of certain white blood cells, leading to their destruction. Obinutuzumab is classified as an anti-cancer agent and is being compared to rituximab in terms of achieving complete remission in patients.

  • Rituximab

    Administered intravenously, rituximab is a well-established medication used in the treatment of CD20-positive acute lymphoblastic leukemia (ALL) among other conditions. It works by binding to the CD20 protein on B-cells, leading to their destruction and is classified as a monoclonal antibody. Rituximab is being compared to obinutuzumab in clinical trials to evaluate its efficacy in achieving complete remission in newly diagnosed adult patients.

Investigated diseases

Acute Lymphoblastic Leukemia – Acute lymphoblastic leukemia (ALL) is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells, known as lymphoblasts. These abnormal cells crowd out normal cells, leading to symptoms such as fatigue, fever, and increased risk of infections. The disease progresses rapidly, requiring prompt medical attention. It is most commonly diagnosed in children but can also occur in adults. The progression involves the accumulation of these immature cells in the bone marrow and blood, which can spread to other organs if not managed.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517389-40-00Protocol codePALG ALL7 “OVERALL"Estimated enrolment124 patientsSponsorNarodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

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