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Obinutuzumab

Obinutuzumab is a monoclonal antibody medication that targets CD20, a protein found on certain immune cells called B cells. It is being studied in clinical trials for treating several conditions, including different types of lymphoma, leukemia, and autoimmune disorders. This article summarizes key information about ongoing clinical trials investigating the use of obinutuzumab for various medical conditions.

Table of Contents

What is Obinutuzumab?

Obinutuzumab is a medication used to treat certain types of blood cancers. It is known by several names, including Gazyva, Gazyvaro, GA101, and RO5072759[1][2]. Obinutuzumab is a type of drug called a monoclonal antibody, which means it’s a laboratory-made protein designed to target specific cells in the body[3].

How Obinutuzumab Works

Obinutuzumab works by targeting a specific protein called CD20, which is found on the surface of certain white blood cells called B cells. In many blood cancers, these B cells grow out of control. By attaching to the CD20 protein, Obinutuzumab helps the body’s immune system recognize and destroy these cancerous B cells[3].

Obinutuzumab is considered a “type II anti-CD20 antibody,” which means it has been engineered to be more effective at destroying cancer cells compared to older medications that target CD20[4].

Conditions Treated with Obinutuzumab

Obinutuzumab is used to treat several types of blood cancers and related conditions, including:

  • Chronic Lymphocytic Leukemia (CLL): A slow-growing cancer of the blood and bone marrow[2]
  • Follicular Lymphoma (FL): A type of non-Hodgkin lymphoma that affects B cells[2]
  • Diffuse Large B-cell Lymphoma (DLBCL): An aggressive type of non-Hodgkin lymphoma[2]
  • Marginal Zone Lymphoma (MZL): A slow-growing type of non-Hodgkin lymphoma[4]
  • Mantle Cell Lymphoma: A rare type of non-Hodgkin lymphoma[5]
  • Post-transplant Lymphoproliferative Disorder (PTLD): A type of lymphoma that can occur after organ or stem cell transplantation[3]

Researchers are also studying Obinutuzumab for use in certain kidney conditions, such as membranous nephropathy and fibrillary glomerulonephritis[6][7].

How Obinutuzumab is Administered

Obinutuzumab is given as an intravenous (IV) infusion, which means it’s delivered directly into a vein. The typical dose is 1000 mg, but the schedule can vary depending on the condition being treated and other factors[1].

For example, a common schedule for the first treatment cycle might be:

  • Day 1: 100 mg
  • Day 2: 900 mg
  • Day 8: 1000 mg
  • Day 15: 1000 mg

After the first cycle, patients typically receive 1000 mg on day 1 of each subsequent cycle. Treatment cycles are usually 21 or 28 days long, and patients may receive up to 8 cycles of treatment[2].

Effectiveness of Obinutuzumab

Clinical trials have shown that Obinutuzumab can be effective in treating various blood cancers. For example:

  • In follicular lymphoma, Obinutuzumab has shown superior results compared to older treatments like rituximab, both in newly diagnosed patients and those whose cancer has returned after previous treatment[4].
  • In chronic lymphocytic leukemia, Obinutuzumab has demonstrated effectiveness when combined with other medications[4].
  • For post-transplant lymphoproliferative disorder, early studies suggest that Obinutuzumab may be effective in patients whose cancer has returned or not responded to other treatments[3].

The effectiveness of Obinutuzumab can be measured in several ways, including:

  • Overall response rate: The percentage of patients whose cancer shrinks or disappears after treatment
  • Complete response rate: The percentage of patients whose cancer completely disappears after treatment
  • Progression-free survival: How long patients live without their cancer getting worse
  • Overall survival: How long patients live after starting treatment

Potential Side Effects

Like all medications, Obinutuzumab can cause side effects. Some of the most common include:

  • Infusion-related reactions: These can occur during or within 24 hours of receiving the medication and may include fever, chills, and difficulty breathing[1].
  • Increased risk of infections: Because Obinutuzumab affects the immune system, it can increase the risk of developing infections[7].
  • Low blood cell counts: Obinutuzumab can cause a decrease in various types of blood cells, which can lead to fatigue, increased risk of bleeding, or increased risk of infection[1].

Your healthcare team will monitor you closely for these and other potential side effects during treatment.

Ongoing Research

Researchers continue to study Obinutuzumab to learn more about its effectiveness and safety. Some areas of ongoing research include:

  • Using Obinutuzumab in combination with other medications to improve treatment outcomes[8]
  • Testing Obinutuzumab in patients whose cancer has returned after previous treatments[3]
  • Exploring the use of Obinutuzumab in other conditions, such as kidney diseases[6][7]
  • Studying the long-term effects of Obinutuzumab treatment[5]

These ongoing studies help doctors better understand how to use Obinutuzumab effectively and safely in different patient groups.

Condition Trial Phase Key Outcomes Measured Dosing Regimen
Follicular Lymphoma Phase II Overall response rate, Progression-free survival, Overall survival 1000 mg IV on days 1, 8, 15 of cycle 1, then day 1 of subsequent cycles
Chronic Lymphocytic Leukemia Phase II Complete remission rate, Progression-free survival, Overall survival 1000 mg IV on days 1, 8, 15 of cycle 1, then day 1 of subsequent cycles
Membranous Nephropathy Pilot Study Complete or partial remission of nephrotic syndrome, Adverse events 1000 mg IV on days 1, 15, 29, 43
Mantle Cell Lymphoma Phase II Molecular response rate, Progression-free survival, Overall survival 1000 mg IV on days 1, 8, 15, 22
Immune Thrombocytopenia Phase II Overall response rate, Sustained response rate, Safety 1000 mg IV single dose

FAQ

  • What is obinutuzumab and how does it work? Obinutuzumab is a type of medication called a monoclonal antibody. It works by targeting a protein called CD20 that is found on certain immune cells called B cells. By attaching to CD20, obinutuzumab helps the immune system identify and destroy these B cells, which can be helpful in treating certain cancers and autoimmune conditions where B cells are overactive or abnormal.
  • What conditions is obinutuzumab being studied to treat in clinical trials? Obinutuzumab is being investigated in clinical trials for several conditions, including different types of lymphoma (like follicular lymphoma, diffuse large B-cell lymphoma, and mantle cell lymphoma), chronic lymphocytic leukemia, and autoimmune disorders such as immune thrombocytopenia and membranous nephropathy.
  • How is obinutuzumab typically administered in clinical trials? In most clinical trials, obinutuzumab is given as an intravenous (IV) infusion. The dosing schedule can vary, but often includes multiple doses over several weeks or months. For example, a common regimen is 1000 mg given on days 1, 8, and 15 of the first cycle, then 1000 mg on day 1 of subsequent cycles.
  • What are some potential side effects of obinutuzumab? Common side effects of obinutuzumab can include infusion-related reactions, fatigue, nausea, and an increased risk of infections. More serious side effects may include severe allergic reactions, tumor lysis syndrome (in cancer patients), and a rare brain infection called progressive multifocal leukoencephalopathy. Clinical trials are closely monitoring patients for these and other potential side effects.
  • How long do clinical trials for obinutuzumab typically last? The duration of clinical trials for obinutuzumab can vary widely depending on the specific study design and condition being treated. Some trials may last several months, while others follow patients for several years to assess long-term outcomes and safety. Many trials include an initial treatment period followed by a longer follow-up period to monitor for lasting effects and potential late-occurring side effects.

Ongoing Clinical Trials on Obinutuzumab

  • Study of obinutuzumab to reduce PLA2R antibodies in patients with primary membranous nephropathy

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Safe Skin Test Concentrations for Biotherapy Allergies in Patients with Cancer Using Atezolizumab, Daratumumab, and Nivolumab

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • A study evaluating glofitamab and a drug combination for patients with relapsed or refractory diffuse large B-cell lymphoma.

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Belgium Denmark France Germany Poland Spain

  • Study on the Effects of Maplirpacept, Glofitamab, and Obinutuzumab in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma Not Eligible for Stem Cell Transplant

    Not recruiting

    1 1 1 1
    Investigated drugs:
    France Germany Spain

  • Study of Obinutuzumab, Vemurafenib, and Cobimetinib for Hairy Cell Leukemia in Patients Previously Treated with Purine Analogs or Unfit for Chemotherapy

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Italy

  • Study Comparing Shortened vs Standard Chemotherapy with Rituximab for Initial Treatment of High Tumor Burden Follicular Lymphoma in Newly Diagnosed Patients

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Italy

  • Study on Acalabrutinib, Venetoclax, and Obinutuzumab for Untreated Chronic Lymphocytic Leukemia Patients Without del(17p) or TP53 Mutation

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Bulgaria Czechia Denmark France Germany +7

  • Study Comparing Venetoclax and Obinutuzumab with Drug Combination for Fit Patients with Untreated Chronic Lymphocytic Leukemia Without Specific Genetic Mutations

    Not recruiting

    3 1 1 1
    Investigated drugs:
    France Italy Spain

  • Study on the Safety and Effectiveness of Glofitamab and Obinutuzumab for Patients with Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Belgium Czechia Denmark Finland France Italy +2

  • Study of Obinutuzumab as First-Line Treatment for Adult Patients with Marginal Zone Lymphoma Who Are Not Eligible for Local Therapy

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Monoclonal antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. Monoclonal antibodies are used to treat some types of cancer and other diseases.
  • CD20: A protein found on the surface of B cells, which are a type of white blood cell. CD20 is the target of obinutuzumab and some other cancer treatments.
  • Lymphoma: A type of cancer that begins in cells of the lymph system, which is part of the body's immune system.
  • Chronic lymphocytic leukemia (CLL): A type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell).
  • Follicular lymphoma: A type of non-Hodgkin lymphoma that begins in the follicles (clusters of cells) in the lymph nodes.
  • Mantle cell lymphoma: A rare type of B-cell non-Hodgkin lymphoma that usually occurs in middle-aged or older adults.
  • Immune thrombocytopenia (ITP): A blood disorder characterized by a decrease in the number of platelets in the blood, which can lead to easy bruising and bleeding.
  • Membranous nephropathy: A kidney disorder that causes problems with the filtering of waste products from the blood.
  • Intravenous (IV) infusion: A method of delivering medications directly into a vein using a needle or catheter.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • Overall survival (OS): The length of time from either the date of diagnosis or the start of treatment for a disease that patients are still alive.
  • Complete response (CR): The disappearance of all signs of cancer in response to treatment.
  • Partial response (PR): A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.

References