Long-Term Access to Ibrutinib for Patients with Lymphoma, Leukemia, and Other Conditions

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What is this study about?

This clinical trial is focused on providing extended treatment with ibrutinib for individuals who have previously participated in ibrutinib clinical trials and continue to benefit from its use. Ibrutinib is a medication used in the treatment of various conditions, including Follicular Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom Macroglobulinemia, Multiple Myeloma, Marginal Zone Lymphoma, Diffuse Large B-Cell Lymphoma, Urothelial Carcinoma, Breast Cancer, Acute Myeloid Leukemia, Graft vs Host Disease, and Mantle Cell Lymphoma. The purpose of this study is to allow patients who have shown positive results from previous trials to continue receiving ibrutinib, even if it is not commercially available in their region.

Participants in this study will continue taking ibrutinib in the form of a hard capsule, which is taken orally. The study will monitor the long-term effects of ibrutinib and any potential side effects that may arise. Patients will be observed for any serious adverse events, which are significant health issues that may occur during the treatment. The study aims to ensure that patients who benefit from ibrutinib can maintain their treatment regimen and continue to manage their condition effectively.

1 joining the study

Participation in an eligible ibrutinib clinical trial is required. Continued benefit from ibrutinib treatment or restarting treatment is necessary, as determined by the treating physician.

Access to commercial ibrutinib must not be available or reasonably accessible in the region.

Completion of all assessments in the previous study is required, along with a desire to continue treatment with ibrutinib.

Signing an informed consent form approved by an independent ethics committee or institutional review board is necessary.

2 treatment with ibrutinib

Ibrutinib is administered in the form of a hard capsule for oral use.

The treatment involves ongoing continuous administration of ibrutinib. The specific dosage and frequency are determined by the treating physician based on individual needs and previous study protocols.

3 safety and monitoring

Monitoring for any treatment-emergent serious adverse events and adverse events of special interest is conducted, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Regular assessments are performed to ensure the safety and effectiveness of the treatment.

4 end of study

The estimated end date for the study is May 10, 2027.

Continued participation is based on the ongoing benefit from the treatment and the absence of any significant adverse effects.

Who Can Join the Study?

  • The patient must have participated in a previous clinical trial involving ibrutinib, which is a medication used to treat certain types of cancer.
  • The patient should benefit from continuing or restarting treatment with ibrutinib, according to their doctor’s opinion.
  • The patient does not have access to ibrutinib in their region, or it is not easily available to them.
  • The patient must be currently receiving continuous treatment with ibrutinib.
  • The patient must have completed all necessary evaluations in their previous study and wish to continue treatment with ibrutinib.
  • The patient or their legal representative must willingly sign a consent form approved by an independent ethics committee or review board, agreeing to the long-term treatment extension.
  • The patient must not have withdrawn their consent from the previous study.
  • Both male and female patients who can have children must agree to use a highly effective birth control method and a barrier method during treatment and for 90 days after the last dose.

Who Cannot Join the Study?

  • Patients with certain types of cancer, such as Follicular Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom macroglobulinemia, Multiple Myeloma, Marginal Zone Lymphoma, Diffuse Large B-Cell Lymphoma, Urothelial Carcinoma, Breast Cancer, Acute Myeloid Leukemia, Graft vs Host Disease, and Mantle Cell Lymphoma, may not be eligible.
  • Patients who do not meet the age requirements for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not eligible for long-term access to the study medication, ibrutinib, or the drug combinations from the parent study.
  • Patients who are considered part of a vulnerable population, which means they may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich Chorzow Poland
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital Universitario 12 De Octubre Madrid Spain
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen Boras Sweden
Azienda Ospedaliera di Padova Padua Italy
Fakultni Nemocnice Plzen Plzen Czechia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Centre Hospitalier Universitaire De Nantes Nantes France
Icoedqum Cgkzmo Dwbffoguttzkfjits L'hospitalet De Llobregat Spain
Whjvmnzrkdy Wukncvdousfclezvvyfi Cyjcinb Oleeuzfsi I Tatpdnzwsshyv Ib Mksafdlxgfc W Lbape Lodz Poland
Ughvmwmmzn Or Vbdbfkgfef Valladolid Spain
Ubtevnsqlp Dwxll Smuop Dt Romb Lo Szixwpjq Rome Italy
Halheyby Vneo dxmokggs 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
30.03.2017
France France
Not recruiting
30.03.2017
Hungary Hungary
Not recruiting
30.03.2017
Italy Italy
Not recruiting
30.03.2017
Poland Poland
Not recruiting
30.03.2017
Spain Spain
Not recruiting
30.03.2017
Sweden Sweden
Not recruiting
30.03.2017

Trial locations

Investigated drugs:

Ibrutinib is a medication used in this clinical trial to provide long-term treatment for patients who have previously benefited from it in earlier studies. It is designed to help manage certain types of blood cancers by interfering with the growth and spread of cancer cells. This trial aims to continue offering ibrutinib to patients who have shown positive results and meet specific criteria.

Follicular Lymphoma – A type of non-Hodgkin lymphoma that usually grows slowly and affects the lymph nodes. It often presents with painless swelling of lymph nodes and can spread to other parts of the body over time.

Chronic Lymphocytic Leukemia – A cancer of the blood and bone marrow that typically progresses slowly. It is characterized by an increase in white blood cells called lymphocytes, which can lead to symptoms like fatigue and swollen lymph nodes.

Waldenstrom Macroglobulinemia – A rare type of cancer that begins in the white blood cells and is characterized by the overproduction of a protein called immunoglobulin M. This can lead to symptoms such as bleeding, vision problems, and neurological issues.

Multiple Myeloma – A cancer of plasma cells in the bone marrow, leading to bone pain, anemia, and kidney dysfunction. It often progresses with the accumulation of abnormal cells in the bone marrow.

Marginal Zone Lymphoma – A type of slow-growing non-Hodgkin lymphoma that originates in the marginal zone of lymphoid tissue. It can affect the spleen, lymph nodes, or other organs and may cause symptoms like swelling and fatigue.

Diffuse Large B-Cell Lymphoma – A fast-growing type of non-Hodgkin lymphoma that can arise in lymph nodes or outside of them. It often presents with rapidly enlarging masses and can spread quickly to other parts of the body.

Urothelial Carcinoma – A cancer that typically occurs in the bladder but can also affect the ureters and kidneys. It is characterized by the abnormal growth of cells in the lining of the urinary tract.

Breast Cancer – A common cancer that forms in the cells of the breasts, often presenting as a lump or mass. It can spread to other parts of the body through the lymphatic system or bloodstream.

Acute Myeloid Leukemia – A fast-growing cancer of the blood and bone marrow characterized by the rapid production of abnormal white blood cells. It can lead to symptoms such as fatigue, fever, and an increased risk of infections.

Graft vs Host Disease – A condition that can occur after a bone marrow or stem cell transplant, where the donated cells attack the recipient’s body. It can affect various organs and tissues, leading to a range of symptoms.

Mantle Cell Lymphoma – A rare type of non-Hodgkin lymphoma that typically affects older adults and is characterized by the overproduction of B-cells. It often presents with swollen lymph nodes and can spread to other parts of the body.

Trial ID:
2023-507329-40-00
Protocol code:
PCYC-1145-LT
NCT ID:
NCT03229200
Trial Phase:
Therapeutic confirmatory (Phase III)

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