Study of Zanubrutinib and Obinutuzumab for Patients with Relapsed or Refractory Follicular Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Follicular Lymphoma, which is a form of non-Hodgkin lymphoma. The study is specifically looking at cases where the disease has returned or has not responded to previous treatments, known as Relapsed/Refractory Follicular Lymphoma. The trial is testing a combination of two treatments: Zanubrutinib, also known by its code name BGB-3111, and Obinutuzumab. Zanubrutinib is a medication taken orally in capsule form and works by blocking a protein that helps cancer cells grow. Obinutuzumab is given through an infusion into a vein and is a type of antibody that targets cancer cells.

The purpose of this study is to compare the effectiveness of the combination of Zanubrutinib and Obinutuzumab against using Obinutuzumab alone. Participants in the study will be randomly assigned to receive either the combination treatment or Obinutuzumab by itself. The study will monitor how well the treatments work in reducing the cancer and how long the effects last. Participants will receive treatment for a period of up to 30 days, and their response to the treatment will be evaluated by independent experts.

Throughout the study, participants will have regular check-ups to monitor their health and any side effects from the treatments. The study aims to provide valuable information on whether the combination of Zanubrutinib and Obinutuzumab is more effective than Obinutuzumab alone in treating relapsed or refractory follicular lymphoma. This research could potentially lead to improved treatment options for patients with this type of cancer.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient will provide written consent to participate, confirming understanding and agreement to comply with the study requirements.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, physical examination, and laboratory tests to ensure adequate organ function and the presence of measurable disease.

3 randomization

The patient will be randomly assigned to one of two groups: one receiving obinutuzumab alone or the other receiving a combination of obinutuzumab and zanubrutinib.

4 treatment administration

For patients receiving obinutuzumab alone, the medication will be administered intravenously. The specific dosage and frequency will be determined by the study protocol.

For patients receiving the combination treatment, obinutuzumab will be administered intravenously, and zanubrutinib will be taken orally in capsule form. The dosage and frequency will be specified in the study protocol.

5 ongoing assessments

Throughout the study, the patient will undergo regular assessments to monitor response to treatment. This includes physical exams, laboratory tests, and imaging studies to evaluate disease progression or response.

6 completion of treatment

Upon completion of the treatment phase, the patient will undergo a final assessment to determine the overall response to the therapy. This will include a comprehensive review of all collected data.

7 follow-up

After the treatment phase, the patient will enter a follow-up period. During this time, the patient will continue to be monitored for any long-term effects or recurrence of the disease.

Who Can Join the Study?

Must be at least 18 years old at the time of giving consent.
Must have proper organ function, which includes:
- Enough white blood cells called neutrophils (more than 750 per cubic millimeter) without recent medical help to boost them.
- Enough platelets (more than 50,000 per cubic millimeter) without recent medical help or transfusion.
- Kidneys working well enough to clear at least 30 milliliters per minute, which can be measured in different ways.
- Liver enzymes (AST and ALT) should not be more than 3 times the normal limit.
- Total bilirubin in the blood should be less than 2 times the normal limit, unless you have a condition called Gilbert’s syndrome.
Women who can have children must use very effective birth control methods before starting the study, during the study, and for at least 90 days after the last dose of one study drug or 18 months after the last dose of another, whichever is longer. These methods include:
- Hormonal birth control that stops ovulation, like pills, patches, or injections.
- Devices placed inside the uterus.
- Surgical methods like blocking the fallopian tubes.
- Having a partner who has had a vasectomy.
- Choosing not to have sex, if it fits your lifestyle.
Men must agree to use barrier methods of birth control, like condoms, along with other methods during the study and for at least 90 days after the last dose of one study drug or 18 months after the last dose of another, whichever is longer.
Must be able to give written consent and understand what the study involves.
Must have a confirmed diagnosis of a type of cancer called B-cell follicular lymphoma, specifically grades 1, 2, or 3a.
Must have had at least two previous treatments for follicular lymphoma.
Must have previously received a specific type of treatment involving an anti-CD20 antibody and a combination of other drugs.
Must have experienced disease progression after the most recent treatment or have a disease that did not respond to the most recent treatment.
Must have measurable disease, meaning at least one lymph node larger than 2 centimeters or one area outside the lymph nodes larger than 1 centimeter.
Must have tissue samples available that confirm the diagnosis of B-cell follicular lymphoma, or a report confirming the diagnosis if tissue samples are not available.
Must have a performance status score of 0, 1, or 2, which indicates how well you can carry out daily activities.
Must have a life expectancy of at least 6 months.

Who Cannot Join the Study?

Patients who have a different type of cancer than Relapsed/Refractory Follicular Lymphoma cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to follow the study procedures or attend required visits cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have had certain treatments recently that might affect the study cannot participate.
Patients who are allergic to any of the study medications cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Hopital Necker Enfants Malades	Paris	France
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Centre Henri Becquerel	Rouen	France
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Pratia S.A.	Skorzewo	Poland
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
L’Hopital Alexandra Lepeve	Dunkirk	France
Ivtrkymu Cctfsa Dzrggyrymvzlutape	L'hospitalet De Llobregat	Spain
Imwuhmba Bllxnkht	Bordeaux	France

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	14.11.2017
France	Not recruiting	14.11.2017
Italy	Not recruiting	14.11.2017
Poland	Not recruiting	14.11.2017
Spain	Not recruiting	14.11.2017

Trial locations

Investigated drugs:

Zanubrutinib is a medication used in this trial to treat follicular lymphoma, a type of blood cancer. It works by blocking a specific protein in cancer cells, which helps to stop their growth and spread. In this study, zanubrutinib is combined with another medication to see if it improves treatment outcomes for patients whose cancer has returned or did not respond to previous treatments.

Obinutuzumab is another medication used in this trial. It is a type of antibody therapy that targets and attaches to a specific protein on the surface of cancer cells. This helps the immune system to recognize and destroy these cancer cells. In this study, obinutuzumab is used both alone and in combination with zanubrutinib to compare the effectiveness of the treatments.

Investigated diseases:

Follicular lymphoma

Relapsed/Refractory Follicular Lymphoma – This is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It is characterized by the recurrence or persistence of the disease after initial treatment. The disease typically progresses slowly, but it can become more aggressive over time. Patients may experience symptoms such as enlarged lymph nodes, fatigue, and night sweats. The disease can affect various parts of the body, including the lymph nodes, bone marrow, and spleen. As it progresses, it may lead to complications due to the impaired function of the immune system.

Trial ID:

2023-509975-17-00

Protocol code:

BGB-3111-212

NCT ID:

NCT03332017

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Zanubrutinib and Obinutuzumab for Patients with Relapsed or Refractory Follicular Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?