Long-term Study of Zanubrutinib for Patients with B-cell Blood Cancer

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What is this study about?

This clinical trial is focused on studying the long-term effects of a treatment called Zanubrutinib, also known by its code name BGB-3111. The study is specifically for patients with a type of blood cancer known as B-cell malignancies, which affects the lymph nodes. The purpose of the study is to evaluate the long-term safety of Zanubrutinib regimens in patients who have previously participated in a related study sponsored by the company BeiGene.

Participants in this study will continue to receive Zanubrutinib in the form of capsules taken orally. The study is open-label, meaning both the researchers and participants know what treatment is being administered. The study will take place over an extended period, allowing researchers to gather information on the safety and effects of the treatment over time. Some participants may receive a placebo as part of the study design.

The main focus of the study is to monitor the safety of the treatment by observing any side effects or adverse events that occur. Additionally, researchers will assess how long patients remain free from disease progression, the duration of their response to the treatment, and their overall survival. This information will help determine the long-term benefits and risks of using Zanubrutinib for treating B-cell malignancies.

1 joining the study

Participation in this study requires previous involvement in a related study sponsored by BeiGene. Eligibility is determined by the investigator based on the potential benefit and tolerance of the medication zanubrutinib.

2 medication administration

The medication used in this study is zanubrutinib, which is taken orally in the form of a capsule. The dosage and frequency will be determined by the healthcare provider based on individual needs and response to treatment.

3 monitoring and assessments

Regular monitoring will be conducted to assess the safety of zanubrutinib. This includes tracking any side effects or adverse events that may occur during the study period.

The study aims to evaluate the long-term safety of zanubrutinib in patients with B-cell malignancies.

4 study duration

The study is expected to continue until June 30, 2027. Participation duration may vary depending on individual circumstances and the investigator’s assessment.

5 outcome measures

The primary focus is on safety, assessed by the occurrence of any side effects. Secondary outcomes include progression-free survival, duration of response, and overall survival.

Who Can Join the Study?

  • The patient must have a type of cancer called B-cell malignancies.
  • The patient must have been part of a previous study sponsored by BeiGene, either currently participating or having participated recently.
  • The patient should intend to continue or start treatment with a drug called zanubrutinib after certain events, such as the end of the previous study or if the disease progresses.
  • If the disease progresses while on zanubrutinib, the patient and doctor must agree that continuing the treatment is in the patient’s best interest, even if it’s not the standard approach.
  • The patient must be able to tolerate zanubrutinib, meaning they can handle the treatment without needing to stop it permanently.
  • The patient must be within the age range specified for the study.
  • Both male and female patients are eligible to participate.
  • The study may include individuals considered part of a vulnerable population.

Who Cannot Join the Study?

  • Patients who have not participated in a previous BeiGene study for the medication called zanubrutinib.
  • Patients who do not have a type of cancer called B-cell malignancies. This refers to cancers that affect a specific type of white blood cell known as B-cells.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Y Politecnico La Fe Valencia Spain
InterHem Poradnie Specjalistyczne Bialystok Poland
Hospital Universitario De Salamanca Salamanca Spain

Other Sites

Site Name City Country Status
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich Chorzow Poland
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Le Mans Le Mans France
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Pratia S.A. Skorzewo Poland
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Centre Hospitalier Lyon Sud Pierre Benite France
University Hospital Ostrava Ostrava Czechia
Igkixbor Crypqn Djkdlimxtnstukedp L'hospitalet De Llobregat Spain
Wiptomjbbyw Waboossvenentwnepocc Cvnscat Ogdvjohod I Tzguckxscfzfk Ip Mhcwowaedwi W Lidkh Lodz Poland
Sck Kcfxsqam Lmhwlonlb Skrxhpsrneg Grea Sigmaringen Germany
Anvfgpo Swy z oqqw Poznan Poland
Iucxyxcd Rihjxpnhy Pry Ld Ssyccz Ddk Tsbgug Diyo Aggokog Igdl Sybund Meldola Italy
Aoqxcuqmj Urj Amsterdam The Netherlands
Apdljocxpl Plfkwesb Hhwjjsno Da Potia Paris France
Cwoeso Hfslnijpjwj Rcougnqi Ulrzxguefspnk Ds Thhgx Tours France
Akzmqqi Orlcgonmehk Ufcpybtduuvwh Cmjcykxdhdfd Diqkm Spxtsi E Djlgk Sncfwrj Dg Tilkha Turin Italy
Azjyedy Ubwjt Svxftrfmk Lmspmt Da Bmgtctb Bologna Italy
Ukftaaxhetvxad Cllsneu Kaaylwuze Gdansk Poland
Hbsvudec Dj Lh Swvrc Csvf I Scje Pxu Barcelona Spain
Hhnorrnu Vbwd dfrteyne Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
21.01.2020
France France
Not recruiting
21.01.2020
Germany Germany
Not recruiting
21.01.2020
Greece Greece
Not recruiting
21.01.2020
Italy Italy
Not recruiting
21.01.2020
Poland Poland
Not recruiting
21.01.2020
Spain Spain
Not recruiting
21.01.2020
Sweden Sweden
Not recruiting
21.01.2020
The Netherlands The Netherlands
Not recruiting
21.01.2020

Trial locations

Investigated drugs:

Zanubrutinib (BGB-3111) is a medication used in the treatment of B-cell malignancies, which are types of blood cancers affecting B lymphocytes. This medication works by blocking a specific protein that helps cancer cells grow and survive. The trial aims to evaluate the long-term safety of zanubrutinib in patients who have already participated in a previous study involving this medication.

Investigated diseases:

B-cell malignancies – B-cell malignancies are a group of cancers that affect B lymphocytes, which are a type of white blood cell responsible for producing antibodies. These malignancies can include various types of lymphomas and leukemias. The disease often begins in the lymph nodes and can spread to other parts of the body, including the bone marrow and spleen. As the disease progresses, it may lead to symptoms such as swollen lymph nodes, fatigue, fever, and weight loss. The progression can vary significantly depending on the specific type of B-cell malignancy.

Trial ID:
2024-511267-28-00
Protocol code:
BGB-3111-LTE1
Trial Phase:
Therapeutic confirmatory (Phase III)

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