Study on the Safety and Effectiveness of Mosunetuzumab and Atezolizumab for Patients with Relapsed or Refractory Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for certain types of blood cancers, specifically Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia. The treatment being tested is called Mosunetuzumab, which is a type of protein used to target cancer cells. In some parts of the study, Mosunetuzumab is used alone, while in others, it is combined with another medication called Atezolizumab. The purpose of the study is to evaluate the safety and effectiveness of these treatments in patients whose cancer has returned or has not responded to previous treatments.

Participants in the study will receive Mosunetuzumab either as a solution for injection under the skin or as a solution for infusion into a vein. The study will also explore how the body processes the medication, which is known as pharmacokinetics. Some participants will receive a combination of Mosunetuzumab and Atezolizumab, which is also given as a solution for infusion. The study will monitor the participants over time to assess how well the treatment works and to identify any side effects or adverse reactions.

The trial aims to determine the best dose and schedule for using Mosunetuzumab alone or with Atezolizumab. It will also compare the effectiveness of the treatment when given by different methods, such as injection versus infusion. The study is expected to continue until November 2025, and it will provide valuable information on the potential benefits and risks of these treatments for patients with Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia.

1 initial treatment phase

The trial begins with the administration of mosunetuzumab as a single agent. This medication is given through a subcutaneous injection, which means it is injected under the skin.

The dosage and frequency of administration will be determined by the study team based on individual patient needs and responses.

2 combination treatment phase

In this phase, mosunetuzumab is combined with atezolizumab. Atezolizumab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein.

The combination aims to evaluate the safety and effectiveness of the two medications together.

3 monitoring and assessment

Throughout the trial, regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes checking for any side effects and measuring the response to the treatment.

Blood tests and imaging studies may be performed to evaluate the progress of the treatment.

4 dose adjustment

Based on the patient’s response and any side effects experienced, the dosage of mosunetuzumab and atezolizumab may be adjusted.

The goal is to find the most effective dose with the fewest side effects.

5 completion of treatment

The treatment phase concludes once the study objectives are met or if it is determined that the treatment is not effective for the patient.

Final assessments are conducted to evaluate the overall response to the treatment.

6 follow-up

After completing the treatment, follow-up visits are scheduled to monitor the patient’s health and any long-term effects of the treatment.

These visits help ensure the patient’s well-being and gather additional data on the treatment’s impact.

Who Can Join the Study?

Patients must agree to provide tumor samples. For those with non-Hodgkin’s lymphoma (NHL) and more than one measurable tumor, a biopsy from a safe site is needed. For chronic lymphocytic leukemia (CLL) patients, a bone marrow biopsy and blood sample are required.
Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work. They should also have a life expectancy of at least 12 weeks.
Patients must have a confirmed diagnosis of relapsed or refractory NHL or CLL that is expected to show the presence of a specific protein called CD20. There should be no other available treatment that is expected to improve their survival.
For NHL patients only, there must be at least one measurable tumor that is larger than 1.5 cm for nodal tumors or larger than 1.0 cm for tumors outside the lymph nodes, as seen on a CT or MRI scan.
Patients must have adequate liver, blood, and kidney function.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied, which are B-Cell Malignancies.
Patients who have not experienced a return or worsening of their non-Hodgkin’s lymphoma (NHL) or chronic lymphocytic leukemia (CLL) after treatment.
Patients who have not received at least two previous treatments for their condition.
Patients who are not within the specified age range for the study.
Patients who are not able to safely tolerate the study medications.
Patients who are part of a vulnerable population that the study is not designed to include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Universitario De Salamanca	Salamanca	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Utjzkickfv Hmbuuuji Cxvmrhc	Cologne	Germany
Kzqazcod der Ugvlbvyydywt Mmrvcwaa Akj	Munich	Germany
Fmczwfesr Pirx Ly Iqvrwuidlzmup Bvwcrcesl Dvx Hntokvcy Ussfdphprslrn Lv Plu	Madrid	Spain
Hsngzehm Vniu dykclzku	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	03.11.2017
Spain	Not recruiting	03.11.2017

Trial locations

Investigated drugs:

Mosunetuzumab is a medication being studied for its potential to treat patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. It is being tested both as a single agent and in combination with another medication. The trial aims to evaluate its safety, how well it is tolerated by patients, and how the body processes the drug. Researchers are also trying to determine the most effective dose and schedule for using mosunetuzumab.

Atezolizumab is another medication involved in this trial. It is being combined with mosunetuzumab to see if the combination is more effective in treating the same types of cancer. Atezolizumab is known to help the immune system attack cancer cells, and the trial is assessing whether this combination can improve treatment outcomes for patients with relapsed or refractory non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.

Non-Hodgkin’s Lymphoma – This is a type of cancer that originates in the lymphatic system, which is part of the body’s immune system. It involves the abnormal growth of lymphocytes, a type of white blood cell, which can form tumors throughout the body. The disease can progress at varying rates, with some forms being slow-growing and others more aggressive. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can lead to the spread of cancerous cells to other parts of the body. The exact cause of non-Hodgkin’s lymphoma is not well understood, but it involves genetic mutations in the lymphocytes.

Chronic Lymphocytic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of abnormal lymphocytes. It typically progresses slowly and may not cause symptoms for years. As the disease advances, it can lead to symptoms such as fatigue, swollen lymph nodes, and frequent infections. The accumulation of these abnormal cells can interfere with the production of normal blood cells, leading to anemia and other complications. The cause of chronic lymphocytic leukemia is not fully known, but it involves genetic changes in the lymphocytes. The disease is more common in older adults and may be detected during routine blood tests.

Trial ID:

2023-506820-10-00

Protocol code:

GO29781

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Mosunetuzumab and Atezolizumab for Patients with Relapsed or Refractory Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?