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Study of Ibrutinib and Rituximab for Patients with Untreated Marginal Zone Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called marginal zone lymphoma, which is a cancer that affects a part of the immune system known as B-cells. The study is specifically looking at patients who have not yet received treatment for this condition. The trial will use a combination of two medications: ibrutinib and rituximab. Ibrutinib is taken as a capsule by mouth, while rituximab is given as an injection under the skin or through an infusion into a vein. The purpose of the study is to evaluate how effective this combination is in treating marginal zone lymphoma.

Participants in the study will receive the treatment over a period of time, with ibrutinib being taken daily and rituximab administered at specific intervals. The study will monitor the participants’ response to the treatment, looking at how well the cancer responds and any side effects that may occur. The trial will also explore the treatment’s effects on different subtypes of marginal zone lymphoma, including extranodal marginal zone lymphoma (EMZL), splenic marginal zone lymphoma (SMZL), and nodal marginal zone lymphoma (NMZL).

The study aims to gather information on the complete response rate, which is the percentage of patients whose cancer disappears after treatment, and the progression-free survival, which is the length of time during and after treatment that a patient lives with the disease without it getting worse. Safety and overall survival will also be assessed. This information will help determine the potential benefits and risks of using ibrutinib and rituximab together for treating marginal zone lymphoma.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Blood tests and imaging studies may be performed to evaluate the current state of the lymphoma.

2 treatment initiation

The treatment phase begins with the administration of ibrutinib and rituximab.

Ibrutinib is taken orally in the form of 140 mg hard capsules. The dosage and frequency are determined by the study protocol.

Rituximab is administered in two forms: a 1400 mg solution for subcutaneous injection and a 500 mg concentrate for intravenous infusion. The method of administration is based on the specific requirements of the study.

3 ongoing treatment and monitoring

Throughout the study, regular monitoring is conducted to assess the response to treatment and manage any side effects.

This includes periodic blood tests, imaging studies, and clinical evaluations to track progress and adjust treatment as necessary.

4 evaluation of response

At 12 months, the primary endpoint is evaluated, focusing on the complete response rate.

The study also assesses progression-free survival over a period of 5 years, as well as overall response rates at 12 and 24 months.

5 safety assessment

Safety is evaluated through the assessment of laboratory parameters and the documentation of any adverse events.

The study uses the NCI Common Toxicity Criteria to classify and manage any side effects experienced during the trial.

6 long-term follow-up

Participants are followed up for overall survival and long-term safety outcomes.

The study is expected to continue until October 2027, with ongoing assessments to ensure the well-being of participants.

Who Can Join the Study?

  • Patients must have a type of cancer called CD20-positive marginal zone B-cell lymphoma (MZL) that has not been treated before and is causing symptoms.
  • Patients should not have had chemotherapy or immunotherapy before.
  • Patients must need treatment and cannot be treated with local therapy like surgery or radiotherapy.
  • Patients with a specific type of MZL called EMZL (MALT Lymphoma) must have a score of 1-3 on a scale called MALT-IPI and need systemic therapy.
  • Patients with gastric MALT Lymphoma can join if they are H. pylori-negative or have specific conditions related to H. pylori-positive cases.
  • Patients with ocular adnexal lymphoma treated with antibiotics may also be considered.
  • Patients must have adequate kidney function.
  • Women who can have children must have a negative pregnancy test before starting the study.
  • Patients and their partners must use effective birth control during the study and for a period after the study ends.
  • Patients must be able to understand and agree to sign a consent form.
  • Patients with SMZL who need treatment and cannot or do not want to have their spleen removed can join.
  • Patients with NMZL who need treatment and have a widespread disease can join.
  • Patients must have a disease that can be measured or evaluated.
  • Patients must be in Ann Arbor stage II-IV or stage I if they cannot have local therapy.
  • Patients must be at least 18 years old.
  • Patients must have a life expectancy of at least one year.
  • Patients must have an ECOG Performance status of 0-2, which means they are able to carry out daily activities with little or no assistance.
  • Patients must have adequate bone marrow function.

Who Cannot Join the Study?

  • Patients who have already received treatment for their lymphoma.
  • Patients who do not have symptoms related to their lymphoma.
  • Patients whose lymphoma is not confirmed to be CD20-positive. CD20 is a protein found on the surface of some lymphoma cells.
  • Patients who do not have marginal zone B-cell lymphoma (MZL). This is a specific type of lymphoma.
  • Patients who do not need systemic treatment. Systemic treatment is a type of treatment that affects the whole body, not just one part.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Universita’ Politecnica Delle Marche Ancona Italy
ARNAS G. Brotzu Cagliari Italy
Centre Hospitalier Universitaire De Rennes Rennes France
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Azienda Sanitaria Locale Della Provincia Di Biella Ponderano Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre Hospitalier Universitaire De Caen Normandie Caen France
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Alcebdp Osogurdytzj Uhohdbtpysbhy Ctpasdbkdixk Dcpsb Svncxm E Dctjc Stowhzz Ds Tvtldu Turin Italy
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Hramahxb Ucufsjhnahhyia Sxnhxsibbx &cknqoq Hqmhifn dw Hlkqwdeazdi STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
03.10.2019
France France
Not recruiting
03.10.2019
Italy Italy
Not recruiting
03.10.2019
Portugal Portugal
Not recruiting
03.10.2019

Trial locations

Investigated drugs:

Ibrutinib is a medication used in this trial to treat marginal zone lymphomas. It works by blocking a specific protein that helps cancer cells grow and survive. This can help slow down or stop the growth of cancer cells.

Rituximab is another medication used in the trial. It is a type of therapy that targets specific cells in the immune system. By attaching to these cells, rituximab can help the body’s immune system destroy cancer cells more effectively.

Investigated diseases:

Marginal Zone B-cell Lymphoma (MZL) – This is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It is characterized by the presence of cancerous cells in the marginal zone of lymphoid tissues. MZL can be classified into three main subtypes: extranodal marginal zone lymphoma (EMZL), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL). The disease often progresses slowly and may initially present with symptoms such as swollen lymph nodes, fatigue, or abdominal discomfort. As it advances, it may affect various organs and tissues, leading to more pronounced symptoms.

Trial ID:
2023-507886-25-00
Protocol code:
IELSG47
NCT ID:
NCT03697512
Trial Phase:
Therapeutic exploratory (Phase II)

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