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

3 1 1

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

Other Sites

Site Name City Country Status
University Hospital Ostrava Ostrava Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich Chorzow Poland
Centre Hospitalier Le Mans Le Mans France
University Hospital Olomouc Olomouc Czechia
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Ckmrdx Hdsrmzqutyp Dzjkksnddebkx Vjjcsv La Roche sur Yon France
Hgtrtoli Vgri dmkghlxe Barcelona Spain
Atfo Gmadlv Orkvgidy Mhvymdymyxgtw Nqshagdt Milan Italy
Ipgrvupn Ryzgmwksj Pvl Ld Swwpef Dkj Ttmkca Ddvx Acxtpgv Itkf Sitiya Meldola Italy
Avjqlahpe Udl Amsterdam The Netherlands
Utewhalqsunj Mbkypkg Cqkplfy Uytlgnw Utrecht The Netherlands
Aydyyslqx Hoyypvyl Athens Greece
Hdgmijst Chtebt Dv Bdiocbmpa Barcelona Spain
Fpxtudvf Nxynskpxc Bbzz Brno Czechia
Cmjexz Hvrcupoiuzp Rjhexpni Upwyrxxnvhdod Da Tgvjd Tours France
Fpmyzkog Nnahftvkf Kkgwpjzmx Vutdcwnnv Prague Czechia
Areufos Ojriagboyqr Ujyvqfuyltbom Cjpzfoxuxhgi Dyabq Sgfzpj E Ddeen Smprnbg Do Tmnupp Turin Italy
Altjoqe Onnvrqkjvdzzvnnffzzkllxrq Mcgnuxcd Dzdaq Cfaqbc Novara Italy
Vwdcmtqxz Fysfaidn Nryywwntf V Pieti Prague Czechia
Afovlzh Uouom Siaervgui Lnsgda Dw Btshtor Bologna Italy
Uvezcczzneeapj Clzvpca Kiwoyhhlc Gdansk Poland
Hpkbrorn Dv Lf Suxmi Ckqy I Szpp Pbv Barcelona Spain
Aretjvg Sydagdgwp Ucwtoznwvipbo Fnfvbr Cvbysxip Udine Italy
Harzrmqv Uoyrutvazndil Pytpxk Db Hwiwob Dq Mdyxcgicsmk Majadahonda Spain
Iolgwheb Cxfcea Dmmftgakcyvnntkny L'hospitalet De Llobregat Spain
Cmmtekj Otimxenlv Zwsro Lcaevwexwd Ifu Srx Jjnz Z Dblcd Lublin Poland
Wipfknxxcrf Woxygdugvrgowkxqvirn Cjrzugc Omtjjzfyr I Tmfifhxfqvkso Ii Mtegklwkjfd W Ldfgx Lodz Poland
Sliujwt Umauzmwedtrjt Nf 2 Is Dl Jbir Btfxhzq W Bkkogvixiz Bydgoszcz Poland
Sog Kfbqbutc Ljwdnqsjo Spteuodcjaw Ghnb Sigmaringen Germany
Axelofy Stj z ozlp Poznan Poland
Avzfacaclc Pdpvlond Hdnpgcgu Dy Pebcc Paris France
Pxicua Skti Skorzewo Poland
Aqwwpfm Uwbkg Ssqmlgtpv Lzcgst Deoii Rgarzqf Faenza Italy
Althpqn Ostlqdqajtq S Mptxk De Tpurl Terni Italy
Auvkjo Sfhyjwpoxz Zaomykfxza Dordrecht The Netherlands
Sardegi Soffoiobnczxfkp W Bdqltsneo Puldhrzroqu Oyqaujl Okpuhljdlabr Ifjzickzbqchfigalbh Brzozow Poland

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.

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)

Other Trials to Consider

  • A study comparing AZD0486 after reduced chemotherapy versus standard chemotherapy in older or unfit patients with newly diagnosed large B-cell lymphoma

    Recruiting

    3 1 1 1
    Investigated Diseases:
    Belgium Poland
  • A Study of Allo-QuadCAR01-T Cell Therapy for Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

    Recruiting

    2 1 1
    Investigated Drugs:
    Germany