Long-term Study of Ibrutinib for Patients with B-cell Non-Hodgkin’s Lymphoma and Chronic Graft Versus Host Disease

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What is this study about?

This clinical trial is focused on studying the long-term effects of a medication called ibrutinib, which is used to treat certain types of blood cancers, specifically B-cell non-Hodgkin’s lymphoma and a condition known as chronic graft-versus-host disease (cGVHD). The purpose of the study is to gather information on the safety and effectiveness of ibrutinib over an extended period and to continue providing the medication to participants who are already benefiting from it in previous studies.

Participants in this study will continue to receive ibrutinib, which is taken in the form of a capsule. The study will monitor the participants’ health and any changes in their condition while they are on the medication. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects. The study aims to ensure that ibrutinib remains safe and effective for those who have been using it and to understand its long-term impact on their health.

The study will take place over several years, allowing researchers to collect comprehensive data on the long-term use of ibrutinib. Participants will be regularly assessed to track any side effects or changes in their disease status. This information will help in understanding how ibrutinib can be used most effectively in treating these conditions and ensuring the well-being of those who rely on it for their treatment.

1 joining the study

Upon joining the study, ensure that you have been actively participating in a previous ibrutinib clinical study that is now considered complete.

You must have received at least 6 months of treatment with ibrutinib or be transitioning from a comparator treatment to ibrutinib.

A negative blood or urine pregnancy test is required at the start of the study.

2 treatment with ibrutinib

Continue receiving ibrutinib treatment, which is administered orally in the form of a 140 mg capsule.

The frequency and duration of the treatment will be determined by the study protocol and your healthcare provider.

3 monitoring and assessments

Regular monitoring will be conducted to assess the safety and efficacy of the treatment.

Initial safety assessments may be more frequent if you have received less than 6 months of prior ibrutinib treatment.

4 adverse event reporting

Any adverse events experienced during the study will be documented and analyzed.

The primary endpoint of the study is to record the number of participants affected by an adverse event.

5 evaluation of disease status

The study will also evaluate changes in your disease status as a secondary endpoint.

This involves regular assessments to determine the effectiveness of the treatment.

6 completion of the study

The study is estimated to conclude by December 31, 2026.

Upon completion, further instructions will be provided regarding ongoing treatment and follow-up care.

Who Can Join the Study?

  • Participants must be currently involved in a clinical study with a medicine called ibrutinib that is considered completed. They should have received at least 6 months of treatment with ibrutinib.
  • At the start of the study, participants must be actively receiving treatment with ibrutinib alone.
  • Alternatively, participants must have been part of a study where they initially received a different treatment and are now switching to ibrutinib. In this case, the 6-month treatment requirement is not necessary, but they will need more frequent safety checks if they have had less than 6 months of ibrutinib treatment.
  • Participants must agree to use effective birth control methods as defined by the study.
  • Participants must have a negative pregnancy test, either from blood or urine, at the start of the study.

Who Cannot Join the Study?

  • Patients who are not currently enrolled in ibrutinib studies that have been completed.
  • Patients who are not actively receiving treatment with ibrutinib.
  • Patients who do not continue to benefit from ibrutinib treatment.

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

Other Sites

Site Name City Country Status
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Justus-Liebig-Universitaet Giessen Giessen Germany
Pratia S.A. Skorzewo Poland
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Cxyemp Hcfsxyzkwjv Rryfbpad Updtzxesbfsjd Dq Toftw Tours France
Uhrdctjsyhhcir Crsycmj Kyyrbaldx Gdansk Poland
Ukawclecrq Dgkzw Syopr Dz Rmoe Li Sapdspya Rome Italy
Lkrpw Goehykr Hhobtxdu Ok Axtshk Athens Greece
Nikhyita Iyufhdik Ozpynjtst Iuk Miach Sikcaejswofypdoawqassvdhcerb Ifghchps Beutmchn Cracow Poland
Heauvrpl Vikw dzizwnao Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
29.08.2023
France France
Recruiting
29.08.2023
Germany Germany
Recruiting
29.08.2023
Greece Greece
Not recruiting
29.08.2023
Italy Italy
Not recruiting
29.08.2023
Poland Poland
Recruiting
29.08.2023
Portugal Portugal
Not recruiting
29.08.2023
Spain Spain
Recruiting
29.08.2023

Trial locations

Investigated drugs:

Ibrutinib is a medication used in this clinical trial. It is designed to help treat certain types of blood cancers by blocking a specific protein that helps cancer cells grow and divide. The trial aims to gather long-term safety and effectiveness data for patients who have been receiving this medication and continue to benefit from it.

B-cell non-Hodgkin’s lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting B-lymphocytes, which are a type of white blood cell. It typically presents as painless swelling of lymph nodes, but can also affect other organs. The disease can progress at varying rates, with some forms being slow-growing and others more aggressive. As it advances, it may lead to symptoms such as fever, night sweats, and unexplained weight loss. The progression can involve the spread of cancerous cells to other parts of the body, including the bone marrow and spleen.

Chronic graft-versus-host disease (cGVHD) – This condition occurs when donor cells attack the recipient’s body following a stem cell or bone marrow transplant. It can affect multiple organs, including the skin, liver, and digestive tract. Symptoms may include skin rashes, dry mouth, and liver dysfunction. The disease can develop months after the transplant and may persist for a long time. It often leads to chronic inflammation and tissue damage in the affected areas. The progression can vary widely, with some individuals experiencing mild symptoms and others facing more severe complications.

Trial ID:
2023-503803-27-00
Protocol code:
PCI-32765CAN3001
NCT ID:
NCT01804686
Trial Phase:
Therapeutic confirmatory (Phase III)

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