Study of Zanubrutinib and Rituximab Compared to Bendamustine and Rituximab for Patients with Untreated Mantle Cell Lymphoma Ineligible for Stem Cell Transplant

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What is this study about?

This clinical trial is focused on studying a type of cancer called Mantle Cell Lymphoma, which is a rare form of non-Hodgkin’s lymphoma. The study is comparing two different treatment combinations for patients who have not received any prior treatment for this condition and are not eligible for a stem cell transplant. The first treatment combination includes Zanubrutinib (also known by its code name BGB-3111) and Rituximab. The second treatment combination includes Bendamustine and Rituximab. These medications are given to help manage the disease and improve patient outcomes.

The purpose of the study is to compare the effectiveness of these two treatment combinations. Patients participating in the study will receive one of the two treatment combinations. The study will monitor the patients over a period to see how well the treatments work in controlling the disease. The treatments are administered through infusions, which means they are given directly into the bloodstream through a vein. The study will also look at how long the treatments can keep the disease from getting worse and how they affect the patients’ overall health and quality of life.

Throughout the study, patients will be regularly assessed by healthcare professionals to track their progress and any side effects they may experience. The study aims to provide valuable information on which treatment combination is more effective for patients with Mantle Cell Lymphoma who cannot undergo a stem cell transplant. This information could help guide future treatment decisions for this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the patient meets the study criteria.

2 randomization

Patients are randomly assigned to one of two treatment groups. One group receives zanubrutinib plus rituximab, and the other group receives bendamustine plus rituximab.

3 treatment administration

For the group receiving zanubrutinib and rituximab:

1. Zanubrutinib is taken orally in capsule form. The dosage and frequency are determined by the study protocol.

2. Rituximab is administered intravenously as a solution for infusion. The dosage and schedule are specified in the study protocol.

For the group receiving bendamustine and rituximab:

1. Bendamustine is administered intravenously as a solution for infusion. The dosage and schedule are outlined in the study protocol.

2. Rituximab is also administered intravenously as a solution for infusion, with dosage and schedule specified in the study protocol.

4 monitoring and follow-up

Throughout the study, regular monitoring is conducted to assess the patient’s response to treatment. This includes physical exams, laboratory tests, and imaging studies as needed.

Patient-reported outcomes are collected using specific questionnaires to evaluate quality of life and other health-related factors.

5 completion of treatment

Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment. This includes reviewing all collected data and determining the progression-free survival and other outcomes as defined by the study.

Who Can Join the Study?

Must be at least 70 years old, or between 60 and 69 years old with other health issues that prevent a specific type of stem cell treatment. These health issues include:
- A heart function measurement (called cardiac ejection fraction) of 45% or less
- A lung function measurement (called diffusing capacity for carbon monoxide) of 60% or less
- A kidney function measurement (called creatinine clearance) between 30 and 70 mL/min
- A performance status score of 2, indicating a higher risk of side effects from treatment
- A total score greater than 6 on a health rating scale
Men must agree to use certain birth control methods during the study and for a period after the study, depending on the medication used.
Must be able to provide written consent and understand the study requirements.
Must have a kidney function measurement (creatinine clearance) of at least 30 mL/min.
Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL) based on specific medical criteria.
Must not have received any previous treatments for MCL.
Must have a measurable disease, meaning a tumor that can be measured by size.
Must have tissue samples available to confirm the MCL diagnosis or be willing to undergo a new biopsy.
Must have a performance status score of 0, 1, or 2, indicating the ability to perform daily activities.
Must have a life expectancy of at least 3 months.
Must have adequate organ function, including:
- A certain level of white blood cells (called absolute neutrophil count)
- A certain level of platelets, which help with blood clotting
- Liver function tests within a specific range
- A specific level of bilirubin, a substance made by the liver
Women who can become pregnant must use highly effective birth control methods during the study and for a period after the study, depending on the medication used.

Who Cannot Join the Study?

Patients with other types of cancer besides Mantle Cell Lymphoma cannot participate. Mantle Cell Lymphoma is a specific type of cancer that affects the lymph nodes.
Patients who are not within the specified age range for the study cannot participate. The study is designed for certain age groups only.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent situation, are not eligible.
Patients who have any medical condition or are taking any medication that might interfere with the study results cannot participate.
Patients who are pregnant or breastfeeding are not eligible to participate in the study.
Patients who have participated in another clinical trial recently may not be eligible, as it could affect the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Medical University Of Vienna	Vienna	Austria
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre hospitalier universitaire de Liege	Liege	Belgium
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
University Hospital Limerick	Limerick	Ireland
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Petrus-Krankenhaus	Wuppertal	Germany
University Hospital Waterford	Waterford	Ireland
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
MD Anderson Cancer Center	Madrid	Spain
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego	Walbrzych	Poland
Institutul Regional De Oncologie Iasi	Iasi	Romania
Virgen del Rocío University Hospital	Sevilla	Spain
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Centre Hospitalier Le Mans	Le Mans	France
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
University Hospital Galway	Galway	Ireland
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
Pratia S.A.	Skorzewo	Poland
Centre Hospitalier Universitaire De Nantes	Nantes	France
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Vrije Universiteit Brussel	Jette	Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Uniklinikum Salzburg	Salzburg	Austria
Fundeni Clinical Institute	Bucharest	Romania
Objijsespovvrb Lizs Gfed	Linz	Austria
Uyejspredbqx Myemaxc Cxqdkri Gjdnmgrce	Groningen	The Netherlands
Cukn Upacynfkye Hyckogvn	Cork	Ireland
Izdwqrko Czjfko Denlqzvanwrqxlfhz	L'hospitalet De Llobregat	Spain
Svoisdat Pscpmogke Sdb z ozbw	Gdynia	Poland
Awftxidt Dm Rbgkqs Zuuodynlvo Bnas	Goes	The Netherlands
Aszcffd Obhxxzszobz Odkljwcl Rkskdkn Vskqv Svler Cpdldwrd	Palermo	Italy
Uunuexcqxy Hdnxhqqz Ciwdktx	Cologne	Germany
Cspsrc Hlcuqojukgq Uinnhvytgwiqr Dr Dijce	Dijon	France
Eqnpokj Uhwemrybkavw Mxytiny Ckeapmn Rfnbughoc (btlazxf Mkr	Rotterdam	The Netherlands
Awrjnek Owrpzikxyek Ujymxokjewjvw Snfpyx	Siena	Italy
Arkibtd Oyaymgnffpd Uywhobgjysjmt Cqhqhiwzpgxd Dgwso Sawtwz E Dxsma Sqcrkgl Dd Tlaztb	Turin	Italy
Aiddgsp Orgdlokwqwj Ncwxqrwci Sv Aawvoai E Bvhlxi E C Aryoxn Aspybfysupw	Alexandria	Italy
Kbflxtry dqy Umamaekwgcge Mpbbxerx Amo	Munich	Germany
Aptamtf Ucn Iaftx Dl Rvnlsc Ebysfu	Reggio Emilia	Italy
Aeegjzg Uhiwh Scrbtazon Lnshne Df Bdfliea	Bologna	Italy
Uetcqhvomhzbng Cvyfyrz Krqxzbzqo	Gdansk	Poland
Ueywuddiqz On Apbdvcp	Edegem	Belgium
Ulxmzjdyoy Dhfpw Sarln De Rcap Lh Sismhjhd	Rome	Italy
Fmyjpfrnz Psgx La Igibeohyjqcwg Bbbyztlco Dbz Hlmotioa Ujfgpefotbgcb Ln Poc	Madrid	Spain
Wotcmdxvnpo Wxpwmfccxmamcvwkqbaf Csesagr Ogdxuneah I Ttyhambhonwsg Ih Mgrqwyccllz W Ldhkt	Lodz	Poland
Htkbiaev Vuce dqsrgdce	Barcelona	Spain
Iyoswcax Pccngpodkodktsl Ckgsrz Cwltkw	Marseille	France
Iwcilctm Cpmhu	Paris	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.07.2019
Belgium	Not recruiting	01.07.2019
France	Not recruiting	01.07.2019
Germany	Not recruiting	01.07.2019
Ireland	Not recruiting	01.07.2019
Italy	Not recruiting	01.07.2019
Poland	Not recruiting	01.07.2019
Portugal	Not recruiting	01.07.2019
Romania	Not recruiting	01.07.2019
Spain	Not recruiting	01.07.2019
The Netherlands	Not recruiting	01.07.2019

Trial locations

Investigated drugs:

Zanubrutinib (BGB-3111) is a medication being studied for its effectiveness in treating mantle cell lymphoma, a type of cancer that affects the lymph nodes. It works by blocking a specific protein that helps cancer cells grow and survive. This medication is being tested to see if it can help patients live longer without their disease getting worse.

Rituximab is a medication used to treat certain types of cancer, including mantle cell lymphoma. It works by targeting and attaching to a specific protein found on the surface of cancer cells, helping the body’s immune system to destroy them. In this trial, it is used in combination with other medications to see if it improves treatment outcomes.

Bendamustine is a chemotherapy drug used to treat certain types of cancer, including mantle cell lymphoma. It works by damaging the DNA of cancer cells, which stops them from growing and dividing. In this study, it is combined with rituximab to evaluate its effectiveness in treating patients who have not received prior treatment for their lymphoma.

Investigated diseases:

Mantle cell lymphoma

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It typically begins in the outer edge of a lymph node called the mantle zone. The disease often progresses to involve other lymph nodes, bone marrow, and sometimes the spleen and gastrointestinal tract. Patients may experience symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression of Mantle Cell Lymphoma can vary, with some cases advancing more rapidly than others. It is considered a challenging condition due to its tendency to be diagnosed at an advanced stage.

Trial ID:

2023-509908-15-00

Protocol code:

BGB-3111-306

NCT ID:

NCT04002297

Trial Phase:

Therapeutic use (Phase IV)

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Study of Zanubrutinib and Rituximab Compared to Bendamustine and Rituximab for Patients with Untreated Mantle Cell Lymphoma Ineligible for Stem Cell Transplant

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?