Study on Radiotherapy Alone or with Obinutuzumab for Patients with Early Stage 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, specifically in its early stages. The trial is investigating the effects of a treatment called Obinutuzumab, which is a type of medication known as a monoclonal antibody. This medication is being tested in combination with local radiotherapy, a treatment that uses high-energy rays to target and kill cancer cells. The study aims to compare the effectiveness of using radiotherapy alone versus using it together with Obinutuzumab.

The purpose of the study is to determine if the combination of radiotherapy and Obinutuzumab can improve the time patients live without the disease getting worse, known as progression-free survival. Participants in the study will be randomly assigned to receive either radiotherapy alone or radiotherapy combined with Obinutuzumab. The study will follow participants over a period to observe the outcomes and gather data on the effectiveness and safety of the treatments.

Throughout the study, participants will receive regular check-ups and monitoring to assess their health and the progress of the treatment. The trial will help researchers understand whether adding Obinutuzumab to radiotherapy provides better results for patients with early-stage Follicular Lymphoma compared to radiotherapy alone. This research could potentially lead to improved treatment options for individuals diagnosed with this type of cancer.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. The patient must sign an informed consent form, indicating understanding and agreement to participate in the study.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, a physical examination, and necessary laboratory tests to ensure adequate renal and hepatic function.

A PET/CT scan will be performed to determine the stage of the disease, and a bone marrow biopsy will be conducted to ensure it is negative.

3 randomization

The patient will be randomly assigned to one of two groups: the standard arm receiving only local radiotherapy or the experimental arm receiving both local radiotherapy and obinutuzumab.

4 treatment phase

For patients in the experimental arm, obinutuzumab will be administered as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

Both groups will receive local radiotherapy as part of their treatment regimen.

5 monitoring and follow-up

Throughout the treatment phase, the patient will be monitored for response to treatment and any potential side effects. Regular follow-up visits will be scheduled to assess the patient’s health status and progression-free survival.

Additional tests, such as blood tests and imaging studies, may be conducted to evaluate the treatment’s effectiveness and monitor for any adverse events.

6 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation will be conducted to determine the patient’s response to the treatment. This includes assessing complete response rate, overall response rate, and disease-free survival.

The study will also evaluate molecular response and any adverse events experienced during the trial.

Who Can Join the Study?

Must have a confirmed diagnosis of Follicular Lymphoma grade I-IIIA, which is a type of blood cancer.
Must be in Ann Arbor Stage IA or IIA or IE, non-bulky, which means the cancer is in an early stage and not large.
Must be at least 18 years old.
Must have a negative bone marrow biopsy, meaning no cancer cells are found in the bone marrow.
Must have a performance status of 2 or less, which means being able to carry out daily activities with some limitations.
Must have at least one measurable lymph node that is 2.0 cm or larger, as seen on a CT scan or ultrasound.
Must have adequate kidney function, with a creatinine clearance of 40 mL/min or more, which is a measure of how well the kidneys are working.
Must have adequate liver function, with certain liver enzymes and bilirubin levels within specific limits.
Must understand and sign an informed consent form, agreeing to participate in the study.
Must be able to follow the study schedule and requirements.
Must have a life expectancy of at least 3 months.
Must meet specific fertility and pregnancy prevention criteria:
- Women must be postmenopausal, surgically sterile, abstinent, or using effective birth control.
- Men must use a condom plus another contraceptive method or practice true abstinence.
Must not have had any previous treatment for the lymphoma, except for steroid pre-treatment.
Must have a FLIPI score of less than 2, which is a way to assess the risk of the lymphoma.
Must have a centralized assessment of certain cells in the blood and bone marrow.
Must have a centralized review of the lymph node biopsy with specific genetic testing.

Who Cannot Join the Study?

Patients with medical conditions other than early stage Follicular Lymphoma cannot participate. Follicular Lymphoma is a type of blood cancer that affects the lymphatic system.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.
Patients who do not meet other specific health criteria set by the study organizers cannot participate. These criteria are usually related to the patient’s overall health and medical history.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
ARNAS G. Brotzu	Cagliari	Italy
Azienda Unita Sanitaria Locale Della Romagna	Rimini	Italy
Istituto Oncologico Veneto	Padua	Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Universita Cattolica Del Sacro Cuore	Rome	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Ospedale Santa Maria Goretti Latina	Latina	Italy
AORN San Giuseppe Moscati Avellino	Avellino	Italy
Ssd Ematologia ASLTO4	Chivasso	Italy
Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario	Sondrio	Italy
Ospedale Di Sassuolo S.p.A.	Sassuolo	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Azienda Sanitaria Locale Della Provincia Di Biella	Ponderano	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Azienda Ospedaliera Papardo	Messina	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Universita’ Di Pisa	Pisa	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Azienda Ospedaliera S Gerardo Di Monza Laboratorio Per La Terapia Cellulare E Genica Stefano Verri	Monza	Italy
ASL Roma1	Rome	Italy
Ihryfgov Obrcszdtqq Vffpkw	Castelfranco Veneto	Italy
Icoolbjh Rpqsttjuy Psi Lj Szdgkz Dtp Tbxvhg Dnyv Afyihdy Isme Scusrf	Meldola	Italy
Afdfuqq Osbvosxpdri Nkomeqmti Sc Acmaucy E Bgwhhg E C Asrwoy Acngghhaccr	Alexandria	Italy
Ayiehbl Uct Idvof Dp Rqrxrj Ecmvul	Reggio Emilia	Italy
Aykmaya Osllkjugwrv Uwvcthxfubbos Sytxtv	Siena	Italy
Iifkuv Iuombpbk Fxbtawqnyqnqp Orliljdikju	Rome	Italy
Aieojrc Oaqqutasoyr S Gkzocubp Aqcxbmagzq	Rome	Italy
Uzrahrhhkz Dszjx Sdomc Db Rbqc Ls Sjqkwzpk	Rome	Italy
Amipljy Oulmyfabcdq Oiomfnww Rnbneso Vjnit Sgjay Cknhopgi	Palermo	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.12.2023

Trial locations

Investigated drugs:

Obinutuzumab

Obinutuzumab is a medication used in this trial to treat early-stage Follicular Lymphoma. It is an antibody that targets specific cells in the immune system, helping to slow down or stop the growth of cancer cells. In this study, it is being tested in combination with radiotherapy to see if it improves the time patients live without the disease getting worse, compared to using radiotherapy alone.

Radiotherapy is a standard treatment that uses high-energy rays to target and kill cancer cells. In this trial, it is used alone in one group of patients to compare its effectiveness against the combination of radiotherapy and obinutuzumab in treating early-stage Follicular Lymphoma.

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. In its early stages, the disease may not cause significant symptoms, and individuals might feel generally well. Over time, the lymphoma can spread to other parts of the body, including the bone marrow and spleen. As it progresses, symptoms such as fatigue, night sweats, and weight loss may develop. The disease is characterized by periods of remission and relapse, with the potential for transformation into a more aggressive form.

Trial ID:

2022-502775-29-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Radiotherapy Alone or with Obinutuzumab for Patients with Early Stage Follicular Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?