Study of Ibrutinib and Rituximab for Patients with Follicular Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Follicular Lymphoma. Follicular Lymphoma is a slow-growing form of non-Hodgkin lymphoma, which is a cancer that affects the lymphatic system, a part of the immune system. The study is investigating the effects of a medication called Ibrutinib, which is taken as a hard capsule by mouth. Ibrutinib is being tested in combination with another medication called Rituximab, which is commonly used to treat this type of cancer. The trial will compare the combination of Ibrutinib and Rituximab to a combination of a placebo and Rituximab.

The purpose of the study is to see if adding Ibrutinib to Rituximab can help patients live longer without their disease getting worse, which is known as progression-free survival. Participants in the study will be randomly assigned to receive either the Ibrutinib and Rituximab combination or the placebo and Rituximab combination. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased.

Throughout the study, participants will receive regular check-ups and monitoring to assess their health and the effects of the treatment. The study will also look at other outcomes, such as the overall response rate, which measures how well the cancer responds to the treatment, and overall survival, which tracks how long participants live after starting the treatment. The trial aims to provide valuable information on whether the addition of Ibrutinib can improve outcomes for patients with Follicular Lymphoma.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and diagnosis of follicular lymphoma.

Participants must have a confirmed diagnosis of follicular lymphoma and meet other health-related criteria.

2 randomization

Participants are randomly assigned to one of two groups: one receiving ibrutinib with rituximab, and the other receiving a placebo with rituximab.

This process ensures that the study results are unbiased.

3 treatment phase

Participants in the ibrutinib group take ibrutinib capsules orally. The dosage and frequency are determined by the study protocol.

Both groups receive rituximab, which is administered according to the study schedule.

4 monitoring and assessments

Regular monitoring is conducted to assess the health status and response to treatment.

Assessments include measuring progression-free survival, overall response rate, and other health indicators.

5 completion of treatment

The treatment phase continues until the study’s end date or until specific health criteria are met.

Participants are monitored for any adverse effects and overall health outcomes.

6 follow-up

After completing the treatment phase, follow-up assessments are conducted to evaluate long-term health outcomes.

This phase helps in understanding the duration of response and overall survival rates.

Who Can Join the Study?

  • Must have a confirmed diagnosis of follicular lymphoma. This is a type of cancer that affects the lymphatic system. The cancer must be CD20+ and classified as Grade 1, 2, or 3a, and be in Ann Arbor Stage II, III, or IV.
  • Must have a measurable disease, meaning the cancer can be measured in size using medical imaging.
  • Must be 70 years of age or older, or between 60-69 years old with one or more other health conditions.
  • Must meet one or more GELF criteria, which are specific guidelines used to assess the severity of follicular lymphoma.
  • Must have adequate hematologic function, meaning the blood cells are functioning properly, as defined by the study’s guidelines.
  • Must have adequate hepatic and renal function, meaning the liver and kidneys are working well, as defined by the study’s guidelines.
  • Must have an ECOG performance status score of 0-2. This score measures how well a person can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • Must not be incarcerated and must be able to willingly provide informed consent, meaning they understand the study and agree to participate. This includes adults who are not under legal protection or unable to express their consent.

Who Cannot Join the Study?

  • Patients who have previously received treatment for Follicular Lymphoma cannot participate. Follicular Lymphoma is a type of cancer that affects the lymphatic system.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who have any other medical conditions or factors that the study team believes would make it unsafe or inappropriate for them to participate cannot join the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Orszagos Onkologiai Intezet Budapest Hungary
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital Del Mar Barcelona Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Vitaz Sint-Niklaas Belgium
Hospital Universitario Infanta Leonor Madrid Spain
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Hospital Clinico Universitario De Valladolid Valladolid Spain
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
General University Hospital Of Larissa Larissa Greece
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Gasthuiszusters Antwerpen Antwerp Belgium
Hospital Universitario Virgen De Valme Sevilla Spain
Pratia S.A. Skorzewo Poland
General University Hospital Of Patras Patras Greece
Centre Hospitalier De Perigueux Perigueux France
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
University Of Pecs Pecs Hungary
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Gelre Hospitals Zutphen The Netherlands
University Hospital Ostrava Ostrava Czechia
Uniklinikum Salzburg Salzburg Austria
Cyfuyxoop Umrppvgosdupxa Sqaednyan Woluwe-Saint-Lambert Belgium
Amadlix Ogdlpxpjnot Uhpqntglacbgy Prqpv Parma Italy
Iwxlcfjr Cwsrca Daffrsyksthfmnvno L'hospitalet De Llobregat Spain
Sbvkympk Pfuomsgiz Sgx z ooim Gdynia Poland
Cyqljo Hgcacibjavj Vdctfhl Valence France
Lowmk Gxmatfa Hptpmome On Akapmo Athens Greece
Fhgsbmoe noznoswme Mdmhz a Hmoniqp Prague Czechia
Cwijku Hdzjuqtysjn Ec Ucbkawsmntpfr Dn Lmfqglg Limoges France
Iyqcytsk Rgawfkgas Pxu Lr Shmvwf Dcn Tgagbz Dsgx Abgptrw Iini Sxbtab Meldola Italy
Say Exlgiaciz Heeohjmt Tlsdhch Tilburg The Netherlands
Ayaobno Oorfptlyoku Uytvrcisdsrfc Cyvdymbrlpne Dqtey Slcdjh E Damuq Sytjjxv De Tjkcxp Turin Italy
Gikdtkeaznpdrhutd Vvsegaoqa Phll Aynchw Ebudqtlg Ochwrp Komloi Gyor Hungary
Utkokrjhzc Djsdq Snwcx Dl Rbrc Le Swyziuhx Rome Italy
Lpsos Uprjeawfhqzl Mzqvkcd Cghumwk (bukrk Leiden The Netherlands
Hkylhfzy Uewacohitcvum Hcoozpug Tiqjd y Phpebs Igmyicje Cswyih dmwmtzrtggvnsatxp (ndgl Badalona Spain
Hnnxdnku Vwbm disrzntk Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.07.2021
Belgium Belgium
Not recruiting
01.07.2021
Czechia Czechia
Not recruiting
01.07.2021
France France
Not recruiting
01.07.2021
Greece Greece
Not recruiting
01.07.2021
Hungary Hungary
Not recruiting
01.07.2021
Italy Italy
Not recruiting
01.07.2021
Poland Poland
Not recruiting
01.07.2021
Portugal Portugal
Not recruiting
01.07.2021
Spain Spain
Not recruiting
01.07.2021
The Netherlands The Netherlands
Not recruiting
01.07.2021

Trial locations

Investigated drugs:

Ibrutinib is a medication used in this trial as a Bruton’s Tyrosine Kinase (BTK) inhibitor. It is being tested to see if it can help prolong the time patients live without their follicular lymphoma getting worse. It is used in combination with another medication to see if it provides better results than using the other medication alone.

Rituximab is a medication used to treat certain types of cancer, including follicular lymphoma. In this trial, it is used as a standard treatment to see if adding another medication can improve its effectiveness in preventing the progression of the disease.

Investigated diseases:

Follicular Lymphoma – Follicular lymphoma is a type of non-Hodgkin lymphoma that typically grows slowly and affects the lymphatic system. It originates from B-lymphocytes, a type of white blood cell, and often presents as painless swelling in the lymph nodes. Over time, the disease can spread to other parts of the body, including the bone marrow and spleen. Patients may experience symptoms such as fatigue, night sweats, and weight loss. The progression of follicular lymphoma can vary, with some individuals experiencing long periods without symptoms. It is considered a chronic condition that may require ongoing monitoring and management.

Trial ID:
2023-507271-21-00
Protocol code:
PCYC-1141-CA
NCT ID:
NCT02947347
Trial Phase:
Therapeutic confirmatory (Phase III)

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